Use case
A buyer-oriented shortlist for quantification and segmentation. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Agada Medical, Ltd.
Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...
Adas3D Medical S.L.
ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from...
Cercare Medical A/S
Cercare Neurosuite with Capillary Function and Oncology Virtual Expert processes CT or MR information to provide perfusion, tissue-blood-volume, diffusion, labeling, and...
FUJIFILM Healthcare Americas Corporation
Synapse PACS 7.6.0 provides medical-image management and processing, including measurements, regional segmentation, clinical calculations, structured reports, comparison, fusion,...
Brainomix Limited
Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
Mighty Oak Medical
Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional...
Keya Medical Technology Co., Ltd.
Coronary plaque and stenosis quantification from CCTA
Imeka Solutions, Inc.
ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...
Neurophet., Inc.
Brain MRI/PET registration, segmentation and quantitative PET assessment
Neurophet., Inc.
Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric...
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative...
BeauBrain Healthcare, Inc.
Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...
Fujifilm Corporation
Fujifilm Synapse 3D Base Tools V7.2 provides trained professionals with two-dimensional, three-dimensional, multiplanar, and related viewing, measurement, and analysis functions...
ABBOTT MEDICAL
Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment...
Dentsply Sirona
DS Core CBCT Anatomy uses CBCT and digital-impression data to provide tooth and jaw segmentation, inferior-alveolar-nerve-canal segmentation, panoramic-curve support, and...
Edgecare, Inc.
EdgeFlow UW20 is a wearable ultrasound system for noninvasive periodic bladder-volume measurement in adults with BMI no greater than 30.
Smart Soft Healthcare AD
Post-process previously acquired cervical-spine MR images to segment vertebrae and disks, calculate quantitative measurements, label out-of-range values, and export results for...
Mim Software, Inc.
Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and...
Voronoi Health Analytics Incorporated
DAFS automatically segments anatomy on DICOM Part 10 CT images and supports reviewed two- and three-dimensional visualization, editing, and area, volume, and intensity...
Beijing Infervision Healthcare Medical Technology Co., Ltd.
InferCare RECIST is a post-processing application for longitudinal medical-image display, lesion measurement, registration, tracking, segmentation, three-dimensional...
Perspectum, Ltd.
LiverMultiScan v6.0 is MR diagnostic software for non-invasive liver-health assessment that generates, displays, and supports review of MR data and quantitative cT1, PDFF, and LIC...
Depuy Ireland UC
VELYS Hip Navigation analyzes intraoperative X-ray or fluoroscopy for total hip arthroplasty with surgeon-confirmed landmark suggestions and measurements of cup orientation, leg...
Orca Dental AI, Ltd.
CEPHX3D processes dental and craniomaxillofacial images to support diagnosis and treatment planning, including three-dimensional models, viewing, segmentation, measurements, and...
Clarius Mobile Health Corp.
Semi-automated measurement of left ventricular ejection fraction during cardiac ultrasound.
Ligence Uab
Ligence Heart is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a...
Exo Imaging
Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the...
Cara Medical, Ltd.
CARA assists adult structural-heart and conduction-system procedure planning by segmenting preprocedural CT, visualizing cardiac chambers and conduction landmarks, and overlaying...
Ai4medimaging Medical Solutions S.A.
Cardiac MRI ventricular function and 2D phase-contrast flow quantification
Siemens Medical Solutions USA, Inc.
MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time...
Median Technologies
eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...
Medicalvr B.V.
Surgical Reality Viewer provides preoperative and intraoperative two-dimensional and three-dimensional visualizations from patient images and normal-anatomy segmentations;...
Neurophet., Inc.
Quantitative brain MRI and amyloid-PET analysis, including volumetric reference-percentile comparison and SUVR quantification, to support physician clinical evaluation.
Manteia Technologies Co., Ltd.
AccuContour 4.0 uses deep-learning contours to support segmentation of organs at risk on CT images for radiation-treatment planning, evaluation, and adaptation; qualified...
Siemens Healthcare GmbH
Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
Philips Medical Systems Nederland B.V.
AV Vascular assists trained healthcare professionals with visualization, assessment, and quantification of vascular anatomy on CTA and/or MRA for suspected or diagnosed vascular...
Softlink International Private Limited
Imagine Enterprise Suite receives, stores, shares, visualizes, quantifies, and processes images from multiple modalities; MPXA-2000 supports coronary-angiography calculation with...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and...
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
TOPIA MEDTECH LIMITED
Automated hippocampal labeling, visualization, and volumetric measurement from high-resolution T1-weighted brain MRI, with comparison to a normative healthy-control dataset...
Crescom Co., Ltd.
View and quantify bone age from 2D posteroanterior left-hand radiographs to aid pediatric radiologists assessing patients aged 2-18 years.
Ultrasight, Ltd.
PVAD IQ supports qualified-physician clinical decision support by identifying the aortic annulus and PVAD inlet, calculating their mean distance, and identifying clips acceptable...
Neosoma, Inc.
Neosoma Brain Mets semi-automatically segments and contours previously diagnosed brain metastases on T1 post-contrast brain MRI to support radiation-oncology treatment planning.
Intuitive Surgical, Inc.
IRISeg accepts MR or contrast-enhanced CT images for manual and machine-learning image analysis and segmentation and produces visual three-dimensional models for preoperative...
Overjet, Inc.
Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support
Mighty Oak Medical
Acorn 3D Software provides modular image processing, visualization, segmentation, measurement, treatment planning, and three-dimensional-printing support; Acorn Trajectory...
Canon Medical Informatics, Inc.
CT VScore+ evaluates calcified coronary lesions on ECG-gated, non-contrast cardiac CT in patients aged 30 years or older, automatically generating coronary calcium scores and...
Nobel Biocare C/O Medicim NV
Analyzes two-dimensional bitewing and periapical radiographs of permanent teeth in patients aged 15 and older to identify and localize caries, calculus, periapical radiolucency,...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and...
Bench7, Inc.
Provides automated concurrent-read detection and segmentation of caries on bitewing radiographs in patients 18 and older, adding information for the dentist while requiring...
Pie Medical Imaging BV
3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray...
Mighty Oak Medical
Acorn 3D Software with Acorn 3DP Model provides modular image processing, visualization, segmentation, measurements, treatment planning, and three-dimensional models, including...
ViTAA Medical Solutions, Inc.
AiORTA Plan analyzes cardiovascular CT angiography data to provide volumetric visualization and measurements as adjunctive information for licensed healthcare professionals; it is...
Circle Cardiovascular Imaging, Inc.
cvi42 Coronary Plaque supports qualified professionals with viewing, post-processing, and qualitative and quantitative evaluation of adult cardiac CT DICOM images to assess the...
Siemens Healthineers AG
Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens...
Terarecon,Inc.
Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
Imeka Solutions, Inc.
Adjunctive quantitative brain MRI analysis that compares patient measures with normative and longitudinal references; a physician reviews all results and makes the clinical...
Avatar Medical
brAIn Shoulder Positioning assists preoperative planning and visualization for primary total shoulder replacement by segmenting and measuring shoulder CT anatomy and supporting...
Spectrawave, Inc.
SpectraWAVE X1-FFR Software segments coronary vessels and reports vessel dimensions, stenosis quantification, and pressure-drop estimates under the supervision of a cardiologist.
Bunkerhill Health
Detection, localization, and quantification of mitral-annulus calcification on non-gated non-contrast chest CT.
Thirona BV
Quantitative support for thoracic CT interpretation and treatment planning, including emphysema burden, airway/lung segmentation, endobronchial valve assessment and estimated...
Disior Ltd
SMART PCFD uses algorithms to support orthopedic diagnosis and surgical planning for progressive collapsing foot deformity from weight-bearing CT, including three-dimensional...
Ligence, UAB
Automated post-processing and measurement of adult transthoracic echocardiograms to support cardiologist/sonographer review and clinical decision-making.
Quantib BV
Brain WMH automatically labels, visualizes, and volumetrically quantifies white-matter hyperintensities from T2w FLAIR brain MR and returns segmentations, overlays, and...
AIRS Medical Inc.
Adjunctive brain MRI morphometry and lesion-quantification support for qualified healthcare professionals, including segmented overlays, volumetric measurements, normative...
iSchemaView, Inc.
Aortic and iliac artery segmentation, visualization, measurement, and longitudinal tracking as adjunctive physician decision support.
Axial Medical Printing Limited
Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic,...
Diagnoly
FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements...
DGNCT, LLC
Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating...
Springbok, Inc. (dba Springbok Analytics)
Automatic MRI segmentation and quantitative analysis of muscle, bone, fat, and other anatomical structures to assist visualization and measurement; not direct disease diagnosis.
Qure.ai Technologies
Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.
Careverse Technology Pte. Ltd.
Careverse CoronaryDoc is a web-based tool for trained medical professionals to view and analyze CCTA CT data for coronary plaques and stenosis, with coronary measurements,...
Arterys, Inc.
Multimodality DICOM image management, quantitative analysis, optional cardiovascular MR mapping and flow analysis, and therapy-response lesion tracking for trained clinicians.
Nurea
PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images;...
Galileo CDS, Inc
Post-processing segmentation, quantification, and reporting of brain signal hyperintensities on T2w FLAIR and T1w post-contrast MRI; not detection or specific disease diagnosis.
Artrya Limited
Salix Coronary Plaque (V1.0.0) is a web-based adjunctive tool for qualified cardiologists and radiologists to quantify and characterize coronary plaque and stenosis and perform...
EOS imaging
VEA Align is cloud-based software for orthopedic applications in adult and pediatric populations using two-dimensional X-ray images from EOS imaging systems to display interactive...
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements,...
GE Medical Systems Ultrasound and Primary care Diagnostics
Venue, Venue Go, Venue Fit, and Venue Sprint are general-purpose point-of-care ultrasound systems for trained users across broad adult, pediatric, and neonatal applications, with...
NeuroSpectrum Insights Corp.
Adjunctive quantitative brain-mapping report for qualified clinical interpretation of children 24-36 months, providing regional volume, surface-area and local-gyrification...
iSchemaView
Rapid CTA 360 analyzes adult head CTA DICOM images to flag suspected large- and medium-vessel occlusion in specified intracranial and vertebral segments and notify trained...
Peek Health, S.A.
PeekMed is a cloud web system for preoperative orthopedic planning from imported X-ray, CT, and MR images, with two-dimensional and three-dimensional visualization, measurements,...
SimBioSys, Inc.
TumorSight Viz processes dynamic contrast-enhanced breast MRI for patients with biopsy-proven early-stage or locally advanced breast cancer, providing registration, subtraction,...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows, Scenium, and syngo MBF provide PET, SPECT, nuclear-medicine, CT, and MR viewing, manipulation, quantification, longitudinal comparison, and analysis for...
BunkerHill Health
Maximum axial abdominal aortic diameter measurement on CT exams that include L1-L5, as adjunctive unofficial information for physician review.
FUJIFILM Healthcare Americas Corporation
Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting,...
PIUR Imaging GmbH
3D ultrasound reconstruction with physician-reviewed thyroid and nodule quantification and sonographic feature visualization.
Mycardium AI Limited
Transthoracic echocardiography view classification, cardiac structure segmentation, functional measurements and Doppler review and report support.
GE Medical Systems SCS
CardIQ Suite analyzes 2D or 3D cardiac CT DICOM data for visualization and measurement of cardiovascular anatomy, coronary calcium scoring, coronary review, heart-fat estimation,...
Pearl Inc.
Acts as a CADe second reader to detect and segment caries on periapical radiographs of permanent teeth in patients aged 12 years and older; clinicians review the contours and...
GE Medical Systems Israel
Aurora is a SPECT/CT system for nuclear-medicine uptake imaging, standalone CT, anatomical localization, attenuation correction, diagnosis, staging, therapy planning, guidance,...
Viz.ai, Inc.
Viz Subdural+ labels, visualizes, and quantifies subdural collections from single-time-point non-contrast head CT, reporting collection grayscale value, total volume, widest...
Brainlab Ltd.
TraumaCad Neo assists healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying measurements and prosthesis templates on...
Audax d.o.o.
AudaxCeph Cephalogram Analysis Software assists specialized dental practices with storing and presenting patient cephalogram images and treatment planning through landmark...
Roche Molecular Systems, Inc.
Opulus Lymphoma Precision segments and visualizes lesions and measures total metabolic tumor volume in whole-body FDG-PET/CT for patients already diagnosed with FDG-avid lymphoma;...
GE Medical Systems Ultrasound and Primary care Diagnostics
Voluson Performance 16 and 18 are general-purpose diagnostic ultrasound systems for imaging, measurement, display, and analysis of the human body and fluid across the labeled...
iSchemaview Inc.
Brain midline-shift measurement on adult non-contrast CT
Smart Soft Healthcare AD
Post-processing segmentation, measurement, threshold labeling, and export of quantitative lumbar-spine measurements to support clinical review; not diagnosis.
DeepEcho
Detect standard fetal biometry views and assist fetal biometry measurements during prenatal ultrasound acquisition and interpretation.
Infervision Medical Technology Co., Ltd.
Adjunctive pulmonary nodule detection and measurement, including temporal comparison, in chest CT screening of asymptomatic adults aged at least 55 years.
Cube Click, Inc.
Aids dentists reviewing bitewing and periapical radiographs of permanent teeth by detecting/segmenting caries and periapical radiolucencies, identifying restorations and dental...
Pearl Inc.
Second Opinion BLE identifies and displays bone-level measurements in bitewing and periapical radiographs for dental health professionals reviewing permanent teeth in patients age...
Clarius Mobile Health Corp.
Segmentation and semi-automatic, non-invasive median-nerve cross-sectional-area measurement during ultrasound acquisition.
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vscan Air is a wireless handheld point-of-care ultrasound system for broad adult, pediatric, and neonatal applications. K250087 adds deep-learning automatic bladder-volume...
GE Medical Systems SCS
VersaViewer supports two-dimensional, three-dimensional, and four-dimensional medical-image series processing and analysis through customizable layouts, multimodality review, and...
LARALAB GmbH
Cardiac CT segmentation, measurement and valve-intervention planning
Clarius Mobile Health Corp.
Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
Galileo CDS, Inc
Post-processing automatic segmentation, quantification, and reporting of brain FLAIR hyperintensity volumes to support structural MRI review; not disease detection or diagnosis.
Siemens Medical Solutions USA, Inc.
AI-assisted acute-care triage and notification of suspected large-vessel occlusion on contrast-enhanced head CTA to prioritize review; not diagnosis.
CureMetrix, Inc.
cmAngio (V1.6) processes screening mammograms to aid a qualified interpreting physician in the manual process of identifying breast arterial calcification. It detects the presence...
QFR Solutions bv
QFR (3.0) uses paired coronary X-ray angiographic DICOM acquisitions to calculate three-dimensional vessel and lesion measurements and pressure-drop quantification for...
Siemens Healthcare GmbH
syngo Dynamics VA41D is a multimodality, vendor-agnostic cardiology image and information system for management, processing, review, post-processing, and quantification of cardiac...
Hi-D Imaging AG
Pre-procedural cardiovascular anatomy assessment, measurement, visualization, sizing, and planning support for transcatheter aortic valve replacement.
TribusMed Beheer BV
TribusConnect provides remote viewing and manipulation of CT DICOM data for pre- and post-cardiac-intervention review, including volume rendering, heart segmentation, simulated...
Vent Creativity
Vent Creativity Knee v1.0 (Hermes) assists healthcare professionals in transferring CT imaging into bone segmentation and preoperative orthopedic planning outputs, including...
Avatar Medical
brAIn Shoulder Positioning assists shoulder surgeons with preoperative planning and visualization for primary total shoulder replacement by segmenting shoulder CT data and...
Coreline Soft Co., Ltd.
AVIEW assists physicians with quantitative CT analysis of thoracic and cardiac datasets, including lung, lobe, airway, fissure, nodule, coronary calcium, density, measurement, and...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and procedure planning;...
DiA Imaging Analysis Ltd.
Automated echocardiographic LV and RV function, wall-motion and strain, bladder-volume and image-quality measurements for clinician review.
Cleerly, Inc.
Assists trained professionals with coronary-vessel, lumen, vessel-wall, plaque and stenosis visualization and measurements from CCTA; it does not replace clinical judgment.
Ceevra, Inc.
CT and MR 3D segmentation, measurements and interactive models for adult preoperative and intraoperative surgical planning; not primary diagnosis.
Phantomics Inc.
Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including...
Fovia, Inc.
aiCockpit AI Viewer displays DICOM and AI images with annotations, measurements, three-dimensional reformats, and reports for trained healthcare professionals; the physician...
ScanDiags AG
Semi-automatic lumbar MRI segmentation and area and distance measurements with radiologist-approved PDF report to PACS; adjunct only.
Caristo Diagnostics Ltd.
CaRi-Plaque is a web-based post-processing tool for trained operators and healthcare professionals that analyzes previously acquired CCTA DICOM data for coronary plaque...
Brainomix Limited
Brainomix 360 e-ASPECTS registers adult non-contrast brain CT, segments ASPECTS regions, and provides an editable ASPECTS score with highlighted regions and voxel contribution...
Coreline Soft Co., Ltd.
Quantitative coronary-calcium analysis and risk stratification on existing non-contrast, non-gated chest CT studies.
Philips Ultrasound LLC
Ultrasound Workspace reviews, quantifies, and reports structures and function from multidimensional digital medical data from different modalities in cardiovascular, fetal, and...
Gleamer SAS
BoneMetrics is fully automated software that assists trained radiology professionals with Cobb-angle measurement on frontal spine radiographs in patients aged four years or older...
MIM Software Inc.
Contour ProtégéAI+ automatically creates contours on CT and T2 MR DICOM images as an accessory to MIM software for quantitative analysis, adaptive therapy, transfer, and archive;...
BunkerHill Health
Adjunctive opportunistic detection and quantification of aortic valve calcification during routine clinical-care chest CT review; a physician reviews the informational ROI and...
TeraRecon, Inc.
TeraRecon Aorta.CT (1.1.0) automatically segments the aorta and labels 22 aortic anatomical landmarks from adult contrast CTA DICOM for trained professionals' review in...
Prenuvo
Prenuvo Body Composition is software that non-invasively quantifies fat, muscle, and organs from compatible MR DICOM datasets and displays internal body information, including...
Ortho AI LLC
Ortho AI measures lengths, angles, and implant position relative to bone on radiographic images for total hip arthroplasty, total knee arthroplasty, and lumbar-spine fusion...
Orthofix Srl
The OrthoNext Platform System is indicated to assist healthcare professionals in preoperative planning of orthopedic surgery and postoperative planning of orthopedic treatment. It...
MSKai
Assist physicians in reviewing previously acquired lumbar-spine MRI by providing user-confirmed anatomy identification, segmentation, labeling, measurements, and reporting; it is...
Intuitive Surgical Inc.
IRISeg receives DICOM-compliant contrast-enhanced CT images, provides manual and machine-learning-enabled image-analysis and segmentation tools, and creates an output file for a...
Oxford Brain Diagnostics Ltd
Assist trained healthcare practitioners in viewing, analyzing, quantifying, and evaluating MR brain images of adults older than 45 years, including segmentation, normative...
Peek Health, S.A.
PeekMed web is designed to help healthcare professionals perform preoperative planning for surgical procedures using imported patient imaging studies. The FDA material describes...
Riverain Technologies, Inc.
ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT...
Ontact Health Co., Ltd
Assist licensed physicians with quantifying and reporting adult echocardiography from DICOM ultrasound images.
Aidoc Medical, Ltd.
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of contrast-enhanced CT exams that include the aorta...
Exo Inc
Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept...
Koios Medical, Inc.
Koios Decision Support (DS) is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to...
TeraRecon,Inc.
Provide cardiac-chamber segmentations for trained healthcare professionals reviewing adult cardiac MR to assist diagnosis or treatment planning; the physician makes final...
Remedy Logic Inc.
RemedyLogic AI MRI Lumbar Spine Reader (“RAI”) is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired...
Neurophet, Inc.
Neurophet AQUA is intended for Automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data...
SimBioSys, Inc.
Visualize and analyze DCE breast MRI studies for patients with biopsy-proven early-stage or locally advanced breast cancer, including processing, measurements, and configurable...
Circle Cardiovascular Imaging Inc.
View, post-process, and qualitatively and quantitatively evaluate cardiovascular MR and CT images in DICOM format to obtain diagnostic information as part of a comprehensive...
iCardio.ai
Process previously acquired DICOM-compliant cardiac ultrasound images and make automated cardiac measurements to support qualified cardiologists, sonographers, or other licensed...
Verdure Imaging
Tracked B-mode ultrasound acquisition, display, and scoliosis-angle measurement of the spine for trained users as an adjunct to conventional imaging; it is not the sole basis for...
DiA Imaging Analysis Ltd.
Non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function in patients with suspected disease, with...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Versana Premier, Versana Premier Lotus, and LOGIQ F are general-purpose diagnostic ultrasound systems for broad hospital and clinic applications; K242005 adds transesophageal use,...
BodyVision Medical Ltd.
The LungVision System enables users to segment previously acquired 3D CT datasets and overlay and register those segmented datasets with fluoroscopic live X-ray images of the same...
Springbok, Inc.
Automatically segment lower-extremity muscle and bone structures from MRI in patients aged 18 years and older and provide derived muscle volume, bone volume, intramuscular fat...
BunkerHill Health
Estimate the presence and quantity of coronary artery calcium in patients aged 30 years and older from non-contrast ECG-gated chest CT, with informational segmentation and...
PIUR Imaging GmbH
PIUR tUS Infinity supports a computer-aided thyroid ultrasound workflow that identifies thyroid lobes and margins, calculates volume, marks and quantifies nodules, and provides...
Q Bio, Inc.
Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions using whole-body DICOM MR images gathered on a GE MR450W....
Adas3D Medical S.L
ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for...
AIQ Global, Inc.
Quantitative single-timepoint or longitudinal analysis of lesion ROIs on adult PET/CT, including volume, density, and tracer-uptake changes, with a report used as an adjunct to...
Sonic Incytes
Velacur Sonic measures liver tissue stiffness, ultrasound attenuation, and volume density fat fraction with shear-wave and ultrasound measurements to aid clinical management of...
Shanghai United Imaging Healthcare Co.,Ltd.
uMI Panorama GS combines 148 cm axial-field-of-view PET with CT for qualified healthcare professionals across diagnostic, staging, treatment-planning, and response workflows; this...
Imbio, Inc
The Imbio PHA Software device is designed to measure the maximal diameters of the right and left ventricles of the heart, the main pulmonary artery, and the ascending aorta from a...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows, Scenium, and syngo MBF provide trained healthcare professionals with viewing, manipulation, quantification, analysis, and comparison of PET or...
Siemens Medical Solutions USA, Inc.
MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images. The FDA material...
CorTechs Labs, Inc.
NeuroQuant automatically labels, visualizes, and volumetrically quantifies segmentable brain structures and lesions from MR images, optionally using T2 FLAIR and T2* GRE/SWI for...
Qure.ai Technologies
Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.
Smart Soft Healthcare
CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.
MRIMath LLC
Semi-automatic segmentation, labeling, and volumetric quantification of known WHO grade 4 glioblastoma in adults aged 18 years or older using T1 post-contrast or FLAIR MRI.
Exo Imaging
Non-invasive processing of adult ultrasound for cardiac measurements including LVEF, wall thickness, and IVC diameter, plus lung and cardiac image-quality feedback in patients...
GE Medical Systems SCS
Cardiac CT visualization, measurement, segmentation, tracking, labeling, and calcium scoring to support review of cardiovascular anatomy and pathology, coronary artery disease,...
Aisap
AISAP CARDIO V1.0 automatically processes and analyzes acquired cardiac POCUS images and produces a report with diagnostic assessment and measurements, including selected valvular...
Hutom Inc.
RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional...
Mighty Oak Medical
Acorn Segmentation is intended as an image-segmentation interface for transferring CT or CTA images to an output file, measuring, and treatment planning. The output can be used to...
Disior Ltd
Foot and ankle radiograph analysis for orthopaedic visualization, measurements, and preoperative surgical planning by qualified professionals.
EOS imaging
VEA Align uses 2D X-ray images acquired in EOS imaging systems to display interactive landmarks and support global-alignment assessment, angle and length measurements, and...
JLK Inc.
Assist trained radiologists and urologists in reviewing and analyzing prostate MR studies through semi-automatic prostate outlining, multiparametric visualization, and related...
Disior Ltd
Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
Clarius Mobile Health Corp.
Clarius OB AI assists a trained and qualified healthcare professional with measurements of fetal biometric parameters, including head circumference, abdominal circumference, femur...
Surgical Information Sciences, Inc.
SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, GPi, and Vim, and segment implanted leads for surgical review.
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...
Aidoc Medical, Ltd.
Briefcase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal...
Wisdom Technologies., Inc.
DeepContour uses deep-learning CT processing to generate editable organ contours and RTSTRUCT objects for selected adult radiation-treatment planning workflows, with quantitative...
GE Healthcare Japan Corporation
Improve contrast of 120 kVp single-energy body CT images by estimating 50 keV GSI-like images as non-quantitative adjunct information for patients of all ages; the original 120...
Eko.ai Pte. Ltd d/b/a Us2.ai
Us2.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and...
Coreline Soft Co., Ltd.
A VIEW CAC provides quantitative analysis of calcified plaques in the coronary arteries using non-contrast/non-gated Chest er scans. It enables the calculation of the Agatston...
Siemens Healthcare GmbH
AI-Rad Companion Pulmonary is image-processing software that provides quantitative and qualitative analysis from previously acquired CT DICOM images to support radiologists and...
Avicenna.AI
Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device
Edgecare Inc.
EdgeFlow UH10 is an ultrasound device intended to measure urine volume in the bladder noninvasively in professional healthcare facilities such as hospitals and clinics by...
Overjet, Inc
Aid dentists in detecting and segmenting caries on bitewing and periapical radiographs for patients aged 4-11 with primary or permanent teeth; the output is additional information...
Nano-X AI Ltd.
Provide quantitative and qualitative liver analysis and mean attenuation measurement to support clinician evaluation and assessment of fatty liver in patients aged 18-75 whose CT...
Viz.ai, Inc.
Automatically label, visualize, and quantify segmentable brain structures on single-time-point non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and...
Software Nemotec S.L.
NemoScan supports dental CT or cone-beam CT visualization, segmentation, implant and surgical planning, instrument positioning, and guide planning from preoperative maxillofacial...
iSchemaView, Inc.
Rapid Platform v6.0 is image-processing software for trained professionals that views, processes, and analyzes DICOM images from CT and MRI. It supports functional and dynamic...
DASI Simulations
Provide predefined cardiovascular images and measurements to support pre-procedural planning for patients with aortic stenosis being considered for TAVR; cardiologists and...
Thirona BV
The Thirona LungQ software provides reproducible CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The...
EOS imaging
VEA Align is cloud-based orthopedic software that uses 2D frontal and lateral X-ray images acquired in EOS imaging systems to display interactive landmarks and support...
SimBioSys, Inc.
TumorSight Viz analyzes dynamic contrast-enhanced breast MRI for visualization and analysis of biopsy-proven early-stage or locally advanced breast cancer, including registration,...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MI is software for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images within healthcare institutions, with labeled applications for...
Sydney Neuroimaging Analysis Centre Pty Ltd
Automatically annotate, visualize, and quantify segmentable brain structures from brain MRI at one time point or longitudinally; longitudinal analysis is limited to the same...
NICo-Lab B.V.
Provide quantitative perfusion information in brain tissue for suspected ischemic stroke patients using dynamic brain CT perfusion studies; medical imaging professionals use the...
Quibim S.L.
Automatically label and volumetrically quantify segmentable brain structures and white matter hyperintensities (WMH) from MR images in adults and adolescents aged 18 years and...
Disior Ltd
Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and...
GE Medical Systems Ultrasound and Primary care Diagnostics
LOGIQ Totus is a general-purpose diagnostic ultrasound system for trained healthcare professionals to image, measure, display, and analyze the human body and fluid across the...
Circle Cardiovascular Imaging
Myocardial Strain Software Application provides qualitative and quantitative evaluation of cardiovascular MR images, including two-dimensional displacement, velocity, strain,...
Ceevra, Inc.
Process, review, analyze, communicate, and exchange multidimensional CT or MR images, including preliminary segmentation of normal anatomy, for preoperative surgical planning and...
Siemens Healthcare GmbH
Syngo Carbon Clinicals provides advanced visualization tools to prepare and process medical images acquired by modalities such as CT and MR for evaluation, manipulation,...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows VB80A, Scenium VE60, and syngo MBF VB30 support PET, SPECT, nuclear-medicine, CT, and MR viewing, quantification, analysis, longitudinal comparison, organ...
Exo Inc
Exo AI Platform AIP001 processes imported adult ultrasound DICOM images for lung A-line and B-line assessment and cardiac ejection-fraction measurement and reporting.
Axial Medical Printing Limited
Axial3D Insight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for...
Aidoc Medical, Ltd.
Automatic measurement of brain midline shift on non-contrast head CT in adults or transitional adolescents aged 18 years and older, including single-time-point measurement and...
Clarius Mobile Health Corp.
Provide semi-automatic, non-invasive bladder-volume measurements from ultrasound data acquired by the Clarius Ultrasound Scanner using curvilinear or phased-array scanners; a...
MIM Software Inc.
Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, creates machine-learning contours for quantitative analysis, adaptive...
GE Medical Systems Ultrasound and Primary care Diagnostics
LOGIQ E10 is a general-purpose diagnostic ultrasound system for broad adult and pediatric applications; K231966 adds AI-assisted renal measurements, anatomy-based preset and color...
GE Medical Systems Ultrasound and Primary Care Diagnostic
LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems for trained healthcare professionals to image, measure, display, and analyze the human body and fluid...
Carlsmed, Inc.
aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it...
Siemens Medical Solutions USA, Inc.
The ACUSON Sequoia and Sequoia Select systems provide ultrasound images or signals for the labeled fetal, abdominal, pediatric, neonatal cephalic, small-parts, OB/GYN, cardiac,...
MeVis Medical Solutions AG
CT and MRI image analysis, segmentation, visualization, and volumetry for adult abdominal treatment planning and follow-up, including liver surgery, living-donor, transplant, and...
Philips Ultrasound
Lumify is a general-purpose ultrasound system using compatible Android devices and USB transducers; K232500 adds AI-assisted automatic ejection-fraction quantification.
Siemens Medical Solutions U.S.A.
Post-processing image analysis to assist clinicians in viewing, analyzing, and evaluating MR brain images through automated segmentation, quantitative analysis, normative...
Ontact Health Co., Ltd.
Sonix Health quantifies and reports adult echocardiography by or on the order of a licensed physician using B-mode, M-mode, pulsed-wave Doppler, and continuous-wave Doppler images.
Heuron Co., Ltd.
Registration, fusion, display, and quantitative SUVR analysis of brain amyloid PET with MRI support to aid clinician assessment; outputs are reference information, not a...
CureMetrix, Inc.
cmAngio processes screening FFDM and DBT mammograms to detect presence or absence of breast arterial calcifications at study and breast level and mark segments for qualified...
VUNO Inc.
Automate labeling, visualization, and volumetric quantification of segmentable brain structures from MR images for trained medical-imaging professionals.
Momentum Health Inc.
The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...
Stryker Corp.
HipCheck assists surgeons with quantitative measurements for femoroacetabular-impingement procedures by processing intraoperative static fluoroscopic images and superimposing...
Orthofix US LLC
The OFIX MIS App assists healthcare professionals in viewing, storing, and measuring images and planning orthopedic surgeries, including measurements for placement of surgical...
AI Medical AG
Jazz semi-automatically labels, visualizes, and quantifies segmentable brain structures on MR for patients with known multiple sclerosis and/or brain metastasis, with...
Qure.ai Technologies
Automated measurement of cardiac diameter, thoracic diameter, and the cardiothoracic ratio (CTR) on posterior-anterior chest X-rays to aid physicians or licensed practitioners;...
In-Med Prognostics L3C
NEUROShield labels, visualizes, and quantifies hippocampal volume from brain MRI as decision support for neurologists and neuroradiologists.
AIRAmed GmbH
AIRAscore automatically labels, visualizes and quantifies segmentable brain structures from MR images, replacing manual volume measurement and providing reference-adjusted reports...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panorama GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...
Imeka Solutions, Inc.
ANDI processes diffusion-weighted MRI with auxiliary T1 imaging to create 3D white-matter tract maps and microstructure reports for trained medical professionals as adjunctive...
Medical Metrics, Inc.
Analyze spine X-rays to produce static and/or motion metrics from sagittal lumbar and/or cervical radiographs, visualize intervertebral motion through image-registration...
Axial Medical Printing Limited
Axial3DInsight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for...
Exo Inc
Aid quantification of bladder volume from ultrasound images in patients aged two years or older.
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Voluson SWIFT and Voluson SWIFT+ are general-purpose diagnostic ultrasound systems for qualified and trained healthcare professionals to image, measure, display, and analyze the...
Resonance Health Analysis Services Pty Ltd
Provide quantitative volumetric liver fat fraction, proton-density fat fraction, and steatosis grading to support clinical diagnosis and subsequent management decisions for...
MEDICALIP Co., Ltd
DeepCatch analyzes whole-body CT images to segment skin, bone, muscle, visceral fat, subcutaneous fat, internal organs, and central nervous system structures, then calculates...
IB Lab GmbH
IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment...
Imbio, Inc.
Imbio CAC Software is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery...
FEops nv
Enable visualization and measurement of heart and vessel structures for preprocedural planning and sizing of structural-heart interventions, including LAAO and TAVI; qualified...
NEUROPHET, Inc.
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with optional comparison of volumetric data to reference...
GE Medical Systems, LLC
Auto Segmentation generates initial DICOM RT Structure Set contours for 40 organs or subregions from adult contrast or noncontrast CT across head and neck, thorax, abdomen, and...
Surgical Information Sciences, Inc.
SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.
Olea Medical
MR DWI/FLAIR Measurement V1.0 processes brain DWI and FLAIR MRI to calculate ADC maps, segment ADC-hypointense regions, and communicate relative or normalized FLAIR measurements;...
Ceevra, Inc.
Ceevra Reveal 3 processes, reviews, analyzes, communicates, and interchanges multidimensional CT and MR images for preoperative planning and intraoperative display, with...
Bunkerhill, Inc
Adjunctive opportunistic coronary-calcium estimation during routine chest CT review, providing informational segmentation and Agatston estimates for physician assessment rather...
Sonic Incytes
Velacur Sonic measures liver tissue stiffness and ultrasound attenuation to aid clinical management of liver disease within the labeled workflow.
Siemens Medical Solutions U.S.A.
Adjunctive cardiovascular review for radiologists and physicians in emergency medicine, specialty care, urgent care and general practice, including heart volume, coronary calcium...
MIM Software Inc.
Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, machine-learning contour creation for quantitative analysis, adaptive...
RaySearch Laboratories AB (publ)
RayStation 12A is configurable software for radiation therapy and medical oncology that proposes treatment plans from user input. Authorized users may use reviewed and approved...
Synapsica
RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...
Overjet, Inc.
Concurrent-read CADe to aid professionally trained and licensed dentists in detecting and segmenting caries on bitewing and periapical radiographs; the output is additional...
Medipixel, Inc.
Quantified results from X-ray angiographic images of the coronary arteries to support clinical decisions about diagnosis or treatment evaluation in adult patients with coronary...
GE Medical Systems SCS
FlightPlan for Embolization is a post processing software package that helps the analysis of 3D X-ray angiography images. Its output is intended to be used by physicians as an...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...
GE Medical Systems, LLC
Spectral Bone Marrow is an automated image processing software application, utilizing deep learning technology for bone segmentation, to facilitate optimized visualization of bone...
GE Healthcare
The Xeleris V Processing and Review System displays, processes, archives, prints, reports, and networks planar, SPECT, and PET nuclear-medicine data, with optional applications...
Brainomix Limited
Brainomix 360 e-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities...
VideaHealth, Inc.
Videa Perio Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements and visualization of mesial and...
DiA Imaging Analysis Ltd
Non-invasive processing of ultrasound images to detect, measure, and calculate medical parameters of structures and function in patients with suspected disease, with Quality Score...
iSchema View Inc.
Adjunctive measurement of the RV/LV ratio as a clinical metric used by medical professionals to quantify severity of right-heart strain in adults evaluated with CTPA; the...
Clarius Mobile Health Corp.
Clarius AI semi-automatically places calipers for non-invasive measurements of musculoskeletal structures on ultrasound data acquired by the Clarius Ultrasound Scanner.
Circle Cardiovascular Imaging, Inc.
Visualization, measurement, pre-procedural planning and sizing, and post-procedural evaluation for left atrial appendage closure (LAAC); the software is a planning and assessment...
Coreline Soft Co.,Ltd.
AVIEW provides quantitative CT analysis of pulmonary and cardiac anatomy, including lung, lobe, airway, fissure, nodule, coronary calcium, and related measurements and reports to...
Hyperfine, Inc.
BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and...
Avenda Health, Inc.
The Avenda Health AI Prostate Cancer Planning Software is an artificial intelligence (AI)-based decision support software, indicated as an adjunct to the review of magnetic...
Siemens Medical Solutions USA, Inc.
Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for...
Coreline Soft Co.,Ltd
AVIEW RT ACS is a medical image-management and processing system for radiation-treatment planning with deep-learning auto-segmentation evidence described in the exact FDA decision...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion (Musculoskeletal) is an image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to...
CASIS Cardiac Simulation & Imaging Software
QIR Suite is intended to be used for viewing, post-processing, and quantitative evaluation of cardiovascular Magnetic Resonance (MR) images in a DICOM (Digital Imaging and...
Neosoma Inc.
Semi-automatic labeling, visualization, and volumetric quantification of high-grade brain glioma, including WHO grade 3 astrocytoma, grade 4 astrocytoma, and grade 4 glioblastoma,...
Perspectum
LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic device software application for noninvasive liver evaluation that enables the generation, display...
Viz.ai, Inc.
The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of...
Siemens Medical Solutions USA, Inc.
MI View&GO is a multimodality medical-image application for viewing, manipulating, quantifying, analyzing, and comparing PET, SPECT, CT, and MR images across time points in...
Siemens Healthcare GmBh
AI-Rad Companion (Pulmonary) is image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support...
ClearPoint Neuro, Inc.
ClearPoint Maestro Brain Model is intended for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MR images. This...
3D-Side SA
Customize supports adult total ankle arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, treatment-plan review, and...
HeartLung Corporation
The Automated Bone Mineral Density Software Module measures bone mineral density from existing CT by averaging Hounsfield units in trabecular vertebral bone and can calculate age-...
Circle Cardiovascular Imaging Inc
cvi42 Auto is intended to be used for viewing, post-processing, qualitative and quantitative evaluation of cardiovascular magnetic resonance (MR) and computed tomography (CT)...
AI4MedImaging Medical Solutions S.A.
Automatic segmentation and reporting of cardiac function measurements from 1.5T and 3T MR images to support clinical decision-making; results are not intended for standalone...
GE Medical Systems Ultrasound and
Vivid E80, Vivid E90, and Vivid E95 are general-purpose diagnostic ultrasound systems with specialized cardiac applications for imaging, measurement, display, and analysis across...
Dyad Medical, Inc
Process previously acquired DICOM-compliant cardiac ultrasound images and estimate cardiac measurements to support qualified cardiologists, sonographers, or other licensed...
Hyperfine, Inc.
BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and...
Siemens Medical Solutions USA, Inc.
syngo.CT Extended Functionality provides advanced visualization and processing tools for CT-acquired or reconstructed data, including labeled vessel, spectral, pulmonary,...
Smart Soft Healthcare AD
CoLumbo is an image post-processing and measurement software tool that provides quantitative spine measurements from previously-acquired DICOM lumbar spine Magnetic Resonance (MR)...
Elucid Bioimaging Inc.
ElucidVivo A.3 postprocesses contrast multidetector CT to visualize arterial vessels and provide semi-automatic lumen boundaries, stenosis and lumen measurements, vessel length,...
iSchemaView Inc.
Assist hospital networks and trained radiologists with workflow triage by flagging and communicating suspected ICA or MCA-M1 large-vessel occlusion findings in head CTA images.
Quantib BV
Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Versana Balance is a general-purpose diagnostic ultrasound system for imaging, measurement, display, and analysis of the human body and body fluids across the labeled fetal,...
Overjet, Inc.
Overjet Caries Assist is a concurrent-read aid for detecting and segmenting caries on bitewing radiographs of permanent dentition in patients aged 18 years and older; it provides...
Medviso AB
Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and...
MVision AI
MVision AI Segmentation automatically generates initial contours from CT images for radiotherapy planning; the contours are transferred for professional visualization, review,...
EXINI Diagnostics AB
aPROMISE X accepts, stores, displays, manipulates, quantifies, and reports digital medical images from nuclear-medicine imaging using PSMA PET/CT, with tools for marking regions...
Ever Fortune.AI Co., Ltd.
EFAI RTSuite CT HN-Segmentation System automatically delineates head-and-neck organs at risk on adult non-contrast CT images to support radiation-treatment workflows; initial...
NanoxAI Ltd.
Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss...
Siemens Healthcare GmBh
AI-Rad Companion Brain MR VA40 post-processes head MR images to segment and quantify brain structures and white-matter hyperintensities, compare normalized values with healthy...
Carina Medical LLC
INT Contour uses a machine-learning approach to provide initial segmentation and contouring of treatment targets and organs at risk for radiation-treatment planning; qualified...
ClariPi Inc.
ClariPulmo is a non-invasive image analysis software for use with CT images which is intended to support the quantification of lung CT images. The software is designed to support...
Ever Fortune. AI Co., Ltd.
Automatic cardiothoracic-ratio assessment on PA chest X-ray images for adults 20-80 years old in healthcare institutions; results support clinician assessment and are not for...
3D-Side SA
Customize supports adult shoulder arthroplasty planning with CT segmentation, three-dimensional models, implant positioning and sizing, case management, and physician approval; it...
Arterys Inc.
Arterys MICA software is a medical diagnostic application that displays, processes, stores, and transfers DICOM and non-DICOM medical data. It provides the capability to store...
GE Medical Systems SCS
Visualization and measurement of cardiovascular anatomy, chamber mobility, calcium scoring, and follow-up of stents, bypasses, and plaque imaging to aid diagnosis and...
MIM Software Inc.
Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and...
Siemens Medical Solutions USA, Inc.
syngo.CT Extended Functionality provides advanced visualization and processing of CT-acquired or reconstructed data, with labeled trauma, spectral, vascular, pulmonary, oncology,...
Caption Health
The Caption Interpretation Automated Ejection Fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate...
Quantib B.V.
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images, with complementary segmentations, visualizations, and volume...
MEDICREA International, Inc.
The UNiDTM Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons...
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA TTA2.50 analyzes ultrasound to quantify and report cardiovascular, fetal, and abdominal structures and functions, including editable AI-assisted echocardiographic...
Resonance Health Analysis Services Pty Ltd
LiverSmart is indicated to -For Liver Iron Concentration:(i) measure liver iron concentration in individuals with confirmed or suspected systemic iron overload;(ii) monitor liver...
Ultromics Limited
Quantification and reporting of cardiovascular function to support physician diagnosis in adult populations.
Koios Medical, Inc.
Koios DS is an artificial intelligence (AI)/machine learning (ML)-based computer-aided diagnosis (CADx) software device intended for use as an adjunct to diagnostic ultrasound...
DiA Imaging Analysis Ltd
LVivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients...
Siemens Medical Solutions USA, Inc.
Quantitative and qualitative CT analysis to support radiologists and physicians in emergency medicine, specialty care, urgent care, and general practice in evaluating and...
CorTechs Labs, Inc
OnQ Neuro is a fully automated post-processing medical device software intended for analyzing and evaluating neurological MR image data. OnQ Neuro is intended to provide automatic...
Zebra Medical Vision Ltd.
The HealthCCSng is intended for use as a non-invasive post-processing software to evaluate calcified plaques in the coronary arteries, which present a risk for coronary artery...
Samsung Medison CO., LTD.
Samsung V8 is a general diagnostic ultrasound system for broad hospital, clinic, and practice applications; K211945 adds thoracic scanning, AI-based NerveTrack, and AI-based...
Varian Medical Systems, Inc.
AI Segmentation version 2.0 is a cloud web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review, editing, and...
Olea Medical
Visualization, analysis, reporting, lesion measurement, kinetic assessment, and MR-guided breast interventional planning; when interpreted by a skilled physician, information may...
Qure.ai Technologies
Automatic labeling, visualization, and quantification of segmentable brain structures from non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and...
eko.ai Pte. Ltd. d/b/a Us2.ai
Us2.v1 is a fully automated software platform that processes, analyses and makes measurements on acquired transthoracic cardiac ultrasound images, automatically producing a full...
EXINI Diagnostics AB
aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations...
Siemens Medical Solutions USA, Inc.
syngo.via MI WorkFlows, Scenium, and syngo MBF support the viewing, processing, and quantitative review of supported molecular-imaging and cardiac studies in the exact K211459...
Overjet, Inc.
Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels...
MEDO DX Pte. Ltd.
MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules,...
Varian Medical Systems, Inc.
AI Segmentation version 1.0 is a static, cloud-hosted web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review...
Imbio, LLC
The Imbio RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio...
Nines, Inc.
NinesMeasure is a semi-automatic tool indicated for use by trained radiologists to aid in the analysis and review of adult thoracic CT images. NinesMeasure provides quantitative...
Circle Cardiovascular Imaging Inc.
TruPlan provides CT image processing, visualization, measurements, and cardiac procedure-planning workflow support for the labeled use; exact procedure scope and outputs are...
Fujifilm Corporation
Synapse 3D Base Tools is medical-imaging software that provides trained medical professionals tools to aid reading, interpreting, reporting, and treatment planning. It accepts...
DiA Imaging Analysis Ltd
LVivo Software Application non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients...
Perspectum Ltd.
Hepatica (Hepatica v1) is a post-processing medical device software that presents quantified metrics which may contribute to the assessment of a patient's liver health. Hepatica...
Hyperfine Research, Inc
BrainInsight automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images, returning annotated or segmented images, color...
ADM Diagnostics, Inc.
The CorInsights MRI Medical Image Processing Software is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from MR...
Siemens Medical Solutions USA, Inc.
syngo.via molecular-imaging workflows provide viewing, manipulation, quantification, analysis, and comparison of medical images from one or more modalities and time points,...
GE Medical Systems SCS
PROView is an aiding tool for the clinicians to review multi-parametric prostate MR images following PI-RADS guidelines. It displays acquired and reformatted data for...
Coreline Soft Co., Ltd.
AVIEW LCS is intended for the review and analysis and reporting of thoracic CT images for the purpose of characterizing nodules in the lung in a single study, or over the time...
Quantib BV
Quantib Prostate is image post-processing software for processing, visualizing, and editing prostate MRI images. It supports registered multiparametric-MRI viewing, optional...
Perspectum LTD
LiverMultiScan LMSv4 processes abdominal MRI, including liver images, to generate pixel maps and measurements for proton-density fat fraction, T2 star, and corrected T1, with...
Cleerly, Inc.
Web-based post-processing of cardiac CT data from CCTA performed for CAD or suspected CAD to view and analyze coronary plaques/atherosclerosis and stenosis and support measurement...
CorticoMetrics LLC
Automatically label, visualize, and volumetrically quantify segmentable brain structures from MR images; volumetric measurements may be compared with reference percentile data.
DiA Imaging Analysis Ltd
LVivo Seamless non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients with...
GE Healthcare
Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from...
See-Mode Technologies Pte. Ltd.
See-Mode AVA is a stand-alone, image processing software for analysis, measurement, and reporting of DICOM-compliant vascular ultrasound images obtained from carotid and lower...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid T8 and Vivid T9 are general-purpose ultrasound systems specialized for cardiac imaging and intended for qualified and trained healthcare professionals for ultrasound...
Coreline Soft Co., Ltd
AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets and supports quantitative diagnosis, follow-up evaluation, and documentation through lung,...
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA quantifies and reports cardiovascular, fetal, and abdominal structures and functions from supported clinical images and can exchange data with IMAGE-ARENA and...
VIDA Diagnostics Inc.
The VIDA|vision software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations....
GE Medical Systems Ultrasound and
Vivid E80, E90, and E95 are cardiovascular and general diagnostic ultrasound systems; K200743 adds AI-assisted cardiac measurements and Doppler-spectrum recognition, expanded...
Caption Health
Caption Interpretation Automated Ejection Fraction Software processes previously acquired adult transthoracic cardiac ultrasound images, stores and manipulates images, and...
Ezra AI Inc.
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, three-dimensional visualization, and comparison of MR medical images. It supports an oncologic...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes....
MIM Software Inc.
Contour ProtegeAI is used by trained medical professionals as a tool for automated processing of CT and MR medical images. It creates contours with machine-learning algorithms for...
DiA Imaging Analysis Ltd
LVivo Software Application processes ultrasound clips and supports the labeled LVivo EF, SG, SAX, RV, and Bladder measurements and analyses, with user review and editing of...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Brain MR post-processes typical head-MR T1 MPRAGE images to automatically segment and quantify brain structures, compare normalized volumes with healthy reference...
Medo.ai
MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of...
Butterfly Network, Inc.
The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems...
Philips Healthcare
QLAB Advanced Quantification Software is a software application package designed to view and quantify image data acquired on Philips ultrasound systems.
Coreline Soft Co., Ltd
AVIEW LCS reviews and analyzes thoracic CT images to characterize lung nodules in a single study or over time, including nodule measurements and release-specific Lung-RADS...
Philips Ultrasound, Inc.
The K201012 labeling covers Philips EPIQ, Affiniti, CX50, Sparq, and Lumify diagnostic ultrasound systems plus QLAB image viewing and quantification across labeled adult,...
Arterys Inc.
Support-tool image processing for quantitative cardiovascular assessment and oncologic lesion evaluation, quantification, follow-up, and documentation to aid trained healthcare...
GE Medical Systems SCS
Analysis and visualization of liver CT data from DICOM 3.0-compliant CT scans to assess liver morphology and lesion change over time and to process, review, archive, print, and...
Siemens Medical Solutions USA, Inc.
Software provides quantitative and qualitative analysis of previously acquired CT DICOM images to support radiologists and physicians in the evaluation and assessment of...
Fluidda Inc.
Broncholab provides physicians with reproducible CT values for pulmonary tissue for providing quantitative support for diagnosis and follow-up examination. Broncholab can be used...
Galgo Medical S.L
ADAS 3D post-processes contrast cardiac MRI and CTA to visualize and quantify myocardial scar and export reviewed results to electrophysiology navigation systems; it is not...
Philips Healthcare
QLAB Advanced Quantification Software views and quantifies image data acquired on Philips ultrasound systems for professional review, including supported three-dimensional cardiac...
Icometrix NV
icobrain is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR or NCCT images. This software is intended...
Qynapse
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from MR images, with comparison to reference percentile data; not...
Software Nemotec S.L.
NemoScan supports dental implantology by segmenting and transferring anatomy from CT or cone-beam CT images for implant and surgical planning.
MultiModal Imaging Services Corporation (dba HealthLytix)
RSI-MRI+ is indicated for use as automatic post-acquisition image processing software for analysis of diffusion-weighted and anatomical magnetic resonance imaging data. RSI-MRI+...
Ultromics Ltd
EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician...
MEDICALIP Co., Ltd
MEDIP PRO is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and for preoperative treatment...
IB Lab GmbH
The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the joint space width and indicators for presence or absence of radiographic features...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Cardiovascular processes previously acquired CT DICOM studies to support quantitative and qualitative cardiovascular analysis, including heart segmentation and...
3D Systems, Inc.
D2P is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and is also preoperative software for...
EXINI Diagnostics AB
aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Pulmonary processes CT DICOM studies to support lung and lobe segmentation, measurements, density thresholds, and pulmonary-lesion segmentation, measurement, and...
TeraRecon Inc.
iNutrition-Structural Heart Module is a software solution that is intended to assist Cardiologists, Radiologists and clinical specialists with the visualization and measurements...
Perspectum Diagnostics Ltd
LiverMultiScan LMSv3 is MR diagnostic software for non-invasive liver evaluation from abdominal MR images, including automated liver segmentation and proton-density fat fraction,...
Body Vision Medical Ltd.
The LungVision System is intended to enable users to segment previously acquired 3D CT datasets and overlay and register these 3D segmented data sets with fluoroscopic live X-ray...
Perspectum Diagnostics Ltd
MRCP+v1 is indicated for use as a software-based image processing system for non-invasive, quantitative assessment of biliary system structures by facilitating the generation,...
AmCad BioMed Corporation
AmCAD-UO analyzes pharyngeal and upper-airway ultrasonic images to visualize and quantify airway structures for physician evaluation and monitoring.
Quantib BV
Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional...
Elucid Bioimaging Inc.
vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...
AMRA Medical AB
AMRA Profiler is MR diagnostic software for non-invasive fat and muscle evaluation, including liver fat fraction, T2 star, and muscle volume measurements from supported DICOM MR...
icometrix NV
icobrain segments and quantifies brain structures and lesions from MRI or noncontrast CT using cross-sectional and longitudinal workflows with acquisition-consistency limits.
NinePoint Medical, Inc.
The NvisionVLE Imaging System is an imaging tool for evaluating human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional,...
Arterys Inc.
DICOM/non-DICOM image and data management with optional quantitative cardiac MR and oncology lesion evaluation, quantification, follow-up, and documentation support; the software...
Ziosoft, Inc.
Ziostation2 is customer-hardware image-processing software for viewing, quantifying, manipulating, communicating, printing, and managing many radiological image types, with...
AIQ Solutions, Inc.
QTxI manages and evaluates supported DICOM CT and PET studies, including registration, fusion, region-of-interest contouring, quantitative analysis, and evaluation of quantitative...
Bay Labs, Inc.
EchoMD automated ejection fraction software is used to process previously acquired transthoracic cardiac ultrasound images, to store images, and to manipulate and make...
Thirona Corporation
Provide quantitative support for physician diagnosis, follow-up examination, and documentation of pulmonary-tissue images or abnormalities from CT thoracic datasets.
Quantib BV
Automatic brain-structure labeling, visualization, volumetric quantification, and WMH-candidate assessment as complementary information for trained professionals evaluating MR...
Medicrea International
Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and...
Arterys Inc.
Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up;...
Philips Medical Systems Technologies, Ltd.
Illumeo is an image-management system for trained professionals, including radiologists. It is a software package used with general-purpose computing hardware to acquire, store,...
Combinostics Oy
cNeuro cMRI is intended for automatic labeling, quantification and visualization of segmentable brain structures from a set of MR images. the software is intended to automate the...
HOLOGIC, INC.
Quantra 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.
Verathon Incorporated
BladderScan Prime PLUS is a diagnostic ultrasound system with a bladder indication for noninvasive measurement of urine volume in the bladder using the supported probe and device...
CorTechs Labs, Inc
NeuroQuant is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images.
Quantitative Insights, Inc
QuantX is breast MRI software for the labeled management, analysis, visualization, and decision-support workflow; exact image inputs, outputs, and use remain submission-specific.
MEDICREA INTERNATIONAL
Assists healthcare professionals in viewing and measuring images and planning orthopedic surgeries, including generic and spine-related measurements, surgical planning, and...
BODY VISION MEDICAL LTD.
LungVision segments prior 3D CT and registers and overlays it with live fluoroscopic X-ray of the same anatomy to support catheter and device navigation during pulmonary...
Quantib BV
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides...
ARTERYS INC.
Arterys Cardio DL is a web-accessible image post-processing analysis software device used for viewing and quantifying cardiovascular MR images. The device is intended to visualize...
ZEPMED, LLC.
CT CoPilot is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain. This software is intended...
Icometrix
icobrain segments and quantifies brain structures and lesions from T1-weighted and FLAIR MRI using cross-sectional and longitudinal workflows with acquisition-consistency limits.
DIACARDIO, LTD.
Non-invasive processing of previously acquired echocardiographic images to detect and measure the left-ventricular wall and calculate left-ventricular function.
QUANTIB BV
Automatic labeling, visualization, and volumetric quantification of segmentable brain structures from MR images; visualizes and quantifies WMH candidates and provides...
HOLOGIC, INC.
Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.
IMBIO LLC
Quantitative support for physician diagnosis, documentation, and follow-up examination of pulmonary tissue images and abnormalities from CT thoracic datasets
CIRCLE CARDIOVASCULAR IMAGING INC
cvi42 analyzes cardiovascular CT and MRI with MPR, MIP, volume rendering, centerlines, lumen and stenosis measurements, and reporting for qualified professionals.
GE MEDICAL SYSTEMS SCS
Hepatic VCAR analyzes CT liver images to assess liver morphology and liver lesions with automated liver, lobe, segment, lesion, and measurement tools that a clinician can edit and...
RADLOGICS, INC.
The AlphaPoint software is a device that allows review, analysis, and interchange of CT chest images. The software provides segmentation and Hounsfield numerical analysis values...
HOLOGIC, INC.
Quantra version 1.1 calculates a volumetric breast-density ratio from supported Hologic full-field digital mammography images on the Cenova server as an adjunct, not a diagnostic...