Modality
318 source-backed listings mapped to this modality. Use each profile to verify FDA file number, workflow fit, integration, deployment, and unknown fields.
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...
Siemens Medical Solutions USA, Inc.
An extension for syngo.via that assists trained physicians with automated and semi-automated analysis, visualization and reporting of cardiac CT angiography volume datasets for...
Ge Medical Systems, LLC
Enhanced Boundary for PCCT is a deep-learning CT processing function for improved soft-tissue delineation in routine head examinations with or without contrast.
GuideAI Health
Passive workflow prioritization for studies with imaging patterns consistent with possible total arterial occlusion in the specified vessels; not primary diagnosis, screening,...
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
Fujifilm Corporation
Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
Canon Medical Informatics, Inc.
Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
Canon Medical Systems Corporation
Canon Aquilion ONE V2.0 acquires and processes whole-body CT volumes, including head, chest, abdomen, pelvis, cardiac, extremity, inner-ear, and multi-energy examinations with the...
Subtle Medical, Inc.
Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
Aidoc Medical, Ltd.
Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.
Ever Fortune.Ai, Co., Ltd.
Triage notification of suspected appendicitis on contrast-enhanced abdominal CT
Philips Medical Systems Technologies, Ltd.
Spectral CT Verida Family supports the labeled spectral CT acquisition, reconstruction, material-map, and professional-interpretation workflow; exact models, protocols, and...
JLK, Inc.
Notification-only triage of adult non-contrast head CT for suspected intracranial hemorrhage and large-vessel occlusion, with parallel communication to trained clinicians during...
Philips Healthcare (Suzhou) Co., Ltd.
CT Rembra RT, CT Areta RT, and CT Rembra support whole-body diagnostic imaging, oncology, radiotherapy planning, interventional, vascular, neurological, cardiovascular, and...
Ge Healthcare Japan Corporation
True Definition DL is a deep-learning CT reconstruction function that enhances high-contrast spatial resolution for bone and lung imaging on compatible CT systems.
Ge Medical Systems, LLC
Photonova Spectra and Spectra Select are silicon-based spectral photon-counting detector CT systems that acquire cross-sectional body images, multienergy data, monochromatic...
Siemens Medical Solutions USA, Inc.
SOMATOM X.cite and X.ceed with syngo CT VB20 support diagnostic CT, interventions, treatment preparation, radiation-therapy planning, and qualified low-dose lung screening.
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...
Canon Medical Systems Corporation
Aquilion Serve SP V2.0 acquires and displays cross-sectional whole-body CT volumes, with labeled AiCE, PIQE, and CLEAR Motion image-processing functions for supported examinations.
BunkerHill Health
Detect, localize, and estimate the burden of coronary artery calcification on contrast-enhanced chest CT during clinical care.
BunkerHill Health
Detect, localize, and estimate the burden of aortic valve calcification on contrast-enhanced chest CT during clinical care.
Philips Medical Systems Nederland B.V.
AV Cardiac CT assists radiologists, cardiologists and 3D technologists with viewing, processing and analysis of gated cardiac CT data, including coronary anatomy and cardiac...
Harrison-AI Medical Pty, Ltd.
Annalise Enterprise prioritizes and notifies trained CT clinicians of suspected acute infarct on non-contrast brain CT for adults; it is a study-level, non-localizing worklist aid...
Aidoc Medical, Ltd.
BriefCase-Triage CARE Multi-Triage CT analyzes contrast and non-contrast chest, abdomen, or chest/abdomen CT in adults or transitional adolescents aged 18 and older to flag...
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...
Precision Medical Ventures, Inc. Dba Revealdx
Characterization and relative cancer-risk assessment of incidentally detected pulmonary nodules 6-15 mm in adults, with use as one input to follow-up and clinical decision-making...
Aidoc Medical, Ltd.
Adult contrast-enhanced brain CT triage for suspected brain aneurysm findings at least 3.0 mm.
Shanghai United Imaging Healthcare Co., Ltd.
uCT 780 acquires cross-sectional whole-body CT images, including head, neck, cardiac, and vascular examinations, with labeled low-dose lung-cancer-screening use and uWS-CT-Dual...
Aidoc Medical, Ltd.
Adult contrast-enhanced and non-contrast CT triage for 11 chest, abdominal, and pelvic findings: diverticulitis, abdominal-pelvic abscess, appendicitis, intestinal...
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...
Coreline Soft Co.,Ltd
Adjunctive alert and second-reader information for radiologists interpreting non-contrast chest CT in asymptomatic populations; the cleared nodule range is 3-20 mm.
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...
Mlhealth 360
Non-contrast head CT triage for suspected intracranial hemorrhage in adults aged 22 and older.
A2z Radiology Ai, Inc.
Adult abdominal/pelvic CT triage for acute cholecystitis, acute pancreatitis, unruptured AAA, acute diverticulitis, free air, hydronephrosis, and small-bowel obstruction.
Imvaria, Inc.
Fibresolve analyzes lung CT in patients with pulmonary symptoms to provide an adjunct diagnostic-subtype classification for suspected interstitial lung disease and support...
Aidoc Medical, Ltd.
Adult abdominal CT triage for suspected intra-abdominal free gas.
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...
Terarecon,Inc.
Automatic coronary-artery calcium plaque segmentation for downstream calcium scoring.
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...
iSchemaView, Inc.
Aortic and iliac artery segmentation, visualization, measurement, and longitudinal tracking as adjunctive physician decision support.
Qure.ai Technologies
Parallel notification of suspected anterior-circulation large vessel occlusion on acute head CTA for specialist review; notification only, not diagnosis.
iSchemaView Inc.
Triage notification of suspected obstructive hydrocephalus on non-enhanced head CT; not diagnostic.
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,...
Nurea
PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images;...
Twinsight
SurgiTwin is a web pre-surgical knee-planning system that uses patient CT images to provide two-dimensional and three-dimensional planning information and a PDF report for adults...
Brainomix Limited
Triage and notification of suspected intracranial hemorrhage or anterior-circulation LVO on acute non-contrast head CT; not primary diagnosis.
Methinks Software S.L.
Methinks CTA Stroke analyzes acute-setting brain CT angiography in adults over 21 with suspected stroke for suspected large-vessel occlusion in the terminal ICA, MCA-M1, or MCA-M2...
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...
GE Medical Systems, LLC
Revolution Vibe is a general-purpose and cardiac-optimized CT system for head, whole-body, cardiac, and vascular imaging across the labeled age range.
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...
BunkerHill Health
Maximum axial abdominal aortic diameter measurement on CT exams that include L1-L5, as adjunctive unofficial information for physician review.
Circle Cardiovascular Imaging Inc.
ASPECTS scoring and highlighted-region/voxel visualization to assist assessment of ischemic brain injury in known MCA/ICA occlusion within 12 hours from last known well.
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,...
Methinks Software S.L.
Methinks NCCT Stroke analyzes adult non-contrast head CT to flag suspected intracranial hemorrhage and suspected large-vessel occlusion of the ICA, MCA-M1, or MCA-M2 for parallel...
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...
Aidoc Medical, Ltd.
Parallel triage notification of suspected aortic dissection on contrast CT chest/abdomen; compressed previews are not diagnostic.
iSchemaview Inc.
Brain midline-shift measurement on adult non-contrast CT
FUJIFILM Corporation
SCENARIA View acquires axial, helical, dynamic, and interventional CT images of the body, including the head and whole body, supports reformats and volume rendering, and includes...
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.
Shanghai United Imaging Healthcare Co.,Ltd.
uCT ATLAS Astound and uCT ATLAS are whole-body CT systems for head, body, cardiac, and vascular imaging, with dual-energy analysis options and protocol-governed low-dose...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT provides healthcare institutions with tools to view, manipulate, evaluate, and analyze medical CT images, including colon, lung, vessel, brain, cardiac, liver, rib,...
LARALAB GmbH
Cardiac CT segmentation, measurement and valve-intervention planning
Arineta Ltd.
SpotLight and Duo produce cross-sectional images from X-ray transmission data for cardiovascular and thoracic examinations, including heart imaging with or without contrast and a...
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.
BunkerHill Health
Analyzes existing CT images in DICOM format from adults aged 30 years and older to estimate average areal BMD of spinal bones and flag low bone density below a preset threshold,...
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...
V5med Inc.
V5med Lung AI provides concurrent-read adjunctive notification of suspected pulmonary nodules on chest CT; it does not replace radiologist judgment, diagnostic processes, or...
Artrya Limited
Salix Central is a web-based adjunctive tool for qualified professionals to view, post-process, and analyze cardiac CT DICOM images for physician-identified coronary plaque and...
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...
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.
JLK, Inc.
JLK-SDH analyzes non-contrast head CT for suspected hemispheric subdural hemorrhage and sends notification to a clinician for review in parallel to standard care; PACS/mobile...
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.
Aidoc Medical, Ltd.
Parallel-workflow triage and notification of suspected incidental pulmonary embolism on contrast-enhanced images that include the lungs.
Siemens Medical Solutions USA, Inc.
NAEOTOM Alpha.Peak, Alpha, Alpha.Pro, and Alpha.Prime with syngo CT VB20 generate and process cross-sectional CT images for trained staff as an aid in diagnosis, treatment,...
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...
iSchemaView, Inc.
Rapid Neuro3D analyzes adult head-and-neck CTA DICOM from the aortic arch to the vertex, removing bone, tissue, and venous vessels to generate 3D/2D neurovascular visualizations,...
Shanghai United Imaging Healthcare Co., Ltd.
uCT 550 is a CT X-ray system that produces cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes, including...
Arineta Ltd.
SpotLight and SpotLight Duo produce cross-sectional cardiovascular and thoracic CT images, with the Low Dose Lung Cancer Screening Option for the labeled screening workflow, for...
Imvaria, Inc
ScreenDx provides adjunctive positive/negative assessment of interstitial lung findings on DICOM lung CT in patients older than 22 years to support referral for clinical...
Shanghai United Imaging Healthcare Co., Ltd.
uCT 780 produces whole-body cross-sectional CT images, including head, neck, cardiac, and vascular imaging, supports protocol-governed low-dose lung cancer screening and...
Brainomix Limited
Brainomix 360 e-CTA analyzes adult CTA brain DICOM for vessel visualization and post-processing, including MCA vessel-density asymmetry, contrast/phase context, overlays, and MIP...
JLK, Inc.
Notification-only triage of suspected intracranial hemorrhage on non-contrast head CT
Canon Medical Systems Corporation
Aquilion ONE (TSX-308A/3) V1.5 acquires and displays cross-sectional volumes of the whole body, including the head, with the capability to image whole organs in a single rotation....
Imbio, Inc.
Passive referral notification of chest-CT findings suggestive of radiological usual interstitial pneumonia to specialists associated with interstitial-lung-disease centers; not...
Aidoc Medical, Ltd.
Workflow triage and notification of suspect cases with three or more acute rib-fracture (RibFx) pathologies in adults or transitional adolescents aged 18 and older.
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...
VinBrain Joint Stock Company
Support trained professionals in visualizing, evaluating, measuring, and reporting liver and physician-identified liver lesions on multiphase CT; it does not generate diagnoses or...
Ever Fortune.AI, Co., Ltd.
Prioritization and triage of non-contrast head CT cases with features suggestive of midline shift in individuals aged 18 years and older.
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...
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...
Neurocareai Inc.
Notify hospital-network clinicians and neurovascular or neurosurgical specialists of suspected ICH on acute non-contrast head CT in parallel with standard-of-care interpretation;...
Aidoc Medical, Ltd.
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT scans that include the cervical spine, in adults or...
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...
JLK, Inc.
Notification-only parallel workflow analysis of acute brain CTA to identify suspected large-vessel occlusion in the terminal ICA or MCA-M1 and notify a neurovascular specialist...
Shanghai United Imaging Intelligence Co., Ltd.
Assist hospital networks and trained radiologists with workflow triage by flagging and prioritizing non-enhanced head CT studies with suspected intracranial hemorrhage.
Avicenna.AI
Assist hospital networks and appropriately trained physician specialists by flagging suspected acute cervical-spine fractures on cervical-spine CT for triage and prioritization;...
Shanghai United Imaging Intelligence Co., Ltd.
uAI Portal is a software solution for viewing, manipulating, communicating, and storing medical images and for supporting interpretation and evaluation in healthcare institutions....
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...
Nano-X AI Ltd.
Non-invasive post-processing of routine non-gated, non-contrast CT studies containing the entire heart in adults aged 30 to 85 to evaluate coronary calcified plaque and estimate...
Qure.ai Technologies
Quantitative characterization and longitudinal tracking of user-detected solid pulmonary nodules at least 6 mm on chest CT.
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,...
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...
Aidoc Medical, Ltd.
Briefcase-Triage is a radiological computer- aided triage and notification software indicated for use in the analysis of CTPA images, in adults or transitional adolescents aged 18...
SK Inc.
Notification-only triage for suspected acute intracranial hemorrhage on non-contrast brain CT, sharing cases with medical specialists in parallel with standard care.
Disior Ltd
Foot and ankle CT analysis for three-dimensional visualization, measurements, and preoperative surgical planning by qualified orthopaedic professionals.
Circle Cardiovascular Imaging
Assist qualified medical professionals in assessing and evaluating cardiac function from multi-phase, multi-slice cardiovascular CT angiography images.
Avicenna.AI
Parallel worklist triage for suspected vertebral compression fractures in patients aged 50 years and over within the standard-of-care bone-health setting; not a diagnostic device
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...
Heuron Co., Ltd.
Triage and notification of suspected intracranial hemorrhage on non-contrast head CT in adults and transitional adolescents aged 18 years and older, to assist prioritization while...
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...
Philips Healthcare (Suzhou) Co., Ltd.
CT 5300 acquires head and whole-body cross-sectional CT images for diagnosis in adult and pediatric patients and supports low-dose lung-cancer screening under approved protocols.
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...
Ever Fortune.AI, Co., Ltd.
Assist hospital networks and appropriately trained medical specialists in triaging adults aged 22 years and older by flagging suspected aortic dissection or aortic intramural...
Genesis Software Innovations
Preoperative shoulder-arthroplasty planning from adult CT DICOM images, including three-dimensional anatomy and implant-placement planning; it does not diagnose or recommend a...
Canon Medical Systems Corporation
The Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System acquires and displays cross-sectional volumes of the whole body, including the head, with whole-organ imaging in...
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 Medical Solutions USA, Inc.
NAEOTOM Alpha with syngo CT VB10 provides photon-counting CT for diagnosis, treatment and interventional support, and approved low-dose lung screening; this submission explicitly...
Siemens Medical Solutions USA, Inc.
The SOMATOM go and SOMATOM X platform CT systems with SOMARIS/10 syngo CT VB10 generate and process cross-sectional images from X-ray transmission data for trained staff to use as...
Siemens Medical Solutions USA, Inc.
Assist radiologists in prioritizing suspected intracranial hemorrhage, including subarachnoid hemorrhage, on non-contrast head CT through case-level worklist output; the output is...
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
CADx assistance for assessment and characterization of brain tissue abnormalities and early ischemic injury in patients with known MCA or ICA occlusion, using ASPECTS regions and...
Avicenna.AI
Worklist triage and notification for suspected incidental pulmonary embolism on contrast-enhanced CT acquired for another indication; not a diagnostic device
HighRAD Ltd.
Support trained physicians in visualizing and evaluating physician-identified liver lesions on multi-phase reconstructed CT, including lesion size, shape, position, and change...
Innolitics, LLC
Automatically calculate linear and area-based cardiothoracic ratio from a CT study containing the heart to support clinician assessment of possible cardiomegaly; not for...
GE Hangwei Medical Systems Co., Ltd.
Revolution Ascend Sliding produces cross-sectional images by computer reconstruction of X-ray transmission data, including axial, cine, helical, cardiac, and gated acquisitions,...
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...
iSchemaView, Inc.
Adjunct assessment of early ischemic brain tissue injury and extent of disease in adult ischemic-stroke diagnostic imaging workup, typically within 24 hours of last known well
Imvaria, Inc
Fibresolve is a software-only device that receives and analyzes lung computed tomography (CT) imaging data in order to provide a diagnostic subtype classification in suspected...
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...
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...
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...
Canon Medical Systems Corporation
The Aquilion Serve SP (TSX-307B/1) V1.3 acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using...
Aidoc Medical, Ltd.
Four-category coronary artery calcification (CAC) assessment of plaques on non-cardiac-gated, non-contrast CT images that include the heart; preview images are informational and...
Brainomix Limited
Analyze non-contrast head CT images to help hospital networks and trained clinicians triage and prioritize suspected positive findings for intracranial ICA/M1 large-vessel...
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...
Aidoc Medical, Ltd.
Assist appropriately trained medical specialists by providing the maximum abdominal aortic axial diameter from contrast-enhanced CT exams that include the abdominal aorta in...
Aidoc Medical, Ltd.
Case-level triage and notification of suspected central pulmonary embolism on CTPA in adults or transitional adolescents aged 18 years and older, in parallel with standard-of-care...
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...
iSchemaView, Inc.
Triage and notification of suspected hemispheric subdural hemorrhage (SDH) on non-enhanced head CT, in parallel with standard-of-care interpretation; not diagnostic.
Arineta Ltd.
SpotLight and SpotLight Duo are dedicated cardiovascular and thoracic CT systems; K230370 adds optional deep-learning image reconstruction for patients older than 2 years to...
Neusoft Medical Systems Co., Ltd.
The NeuViz 128 Multi-Slice CT Scanner System is a whole-body computed-tomography X-ray system with a continuously rotating X-ray tube and detector array that reconstructs X-ray...
Ever Fortune.AI Co., Ltd.
Case-level prioritization and passive notification for adult non-contrast head CT studies with features suggestive of acute intracranial hemorrhage (ICH); not a stand-alone...
Brainomix Limited
Notification-only, parallel triage of acute-setting brain CTA studies for suspected large-vessel occlusion (LVO), communicating cases to a neurovascular specialist for review; not...
Annalise-AI Pty Ltd.
Study-level triage and prioritization notification for suspected mass effect on non-contrast brain CT in patients aged 22 years and older; not a stand-alone decision or rule-out...
Annalise-AI Pty Ltd
Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of vasogenic edema by providing...
Canon Medical Systems Corporation
The Aquilion Serve acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
TechsoMed
VisAble.IO is a CT image-processing software package for liver-ablation procedures that imports CT images from CT scanners and facility PACS, assists physicians in identifying...
Annalise-AI Pty Ltd
Aid triage and prioritization of adult patients aged 22 years or older with non-contrast brain CT studies containing features suggestive of obstructive hydrocephalus by providing...
iSchemaView Inc.
Assist hospital networks and trained radiologists in routine-care workflow triage by flagging and prioritizing adult studies with suspected unruptured saccular brain aneurysms at...
Brainomix Limited
Provide notification-only parallel workflow triage of adult non-contrast brain CT studies acquired in the acute setting within 24 hours of symptom onset or since last known well...
Siemens Healthcare GmbH
Assist radiologists in detecting solid and subsolid pulmonary nodules during review of multivendor multi-detector CT examinations of the chest; the device is an adjunctive first-...
GE Medical Systems SCS
Use with CT images to automatically generate anatomically focused multi-planar spine reformats, apply vertebral-body and intervertebral-disc labels, and export the results to...
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...
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...
Cedars-Sinai Medical Center: AIM
Autoplaque is intended to provide an optimized non-invasive application to analyze coronary anatomy and pathology and aid in determining treatment paths from a set of Computed...
Bunkerhill, Inc
Adjunctive opportunistic coronary-calcium estimation during routine chest CT review, providing informational segmentation and Agatston estimates for physician assessment rather...
GE Healthcare Japan Corporation
Deep Learning Image Reconstruction is a deep-learning reconstruction method that produces cross-sectional images of the head and whole body from X-ray transmission data acquired...
Yukun (Beijing) Technology Co., Ltd
CerebralGo Plus is an image processing software package to be used by trained professionals, including, but not limited to physicians and medical technicians. The software runs on...
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...
Annalise-AI Pty Ltd
Intended Context Annalise Triage is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the...
Formus Labs, Ltd
CT-based preoperative planning for hip surgery, including interactive implant-geometry overlay and generation of a surgeon-reviewable planning report.
Viz. ai, Inc.
Viz AAA is a radiological computer-assisted triage and notification software device for analysis of CTA images of the abdomen. The device is intended to assist hospital networks...
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...
Canon Medical Systems Corporation
The Aquilion Precision acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
Canon Medical Systems Corporation
The Aquilion Serve acquires and displays cross-sectional volumes of the whole body including the head, provides volume sets for specialized studies using indicated software or...
iSchemaView, Inc.
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is...
Coreline Soft Co.,Ltd.
AVIEW Lung Nodule CAD is a Computer-Aided Detection (CAD) software designed to assist radiologists in the detection of pulmonary nodules (with diameter 3-20 mm) during the review...
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...
Shanghai United Imaging Healthcare Co., Ltd.
uCT ATLAS Astound is a computed-tomography X-ray system that produces cross-sectional images of the whole body and is applicable to head, whole-body, cardiac, and vascular CT; it...
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...
Aidoc Medical, Ltd.
Chest CT (with or without contrast) triage and notification for suspected three or more acute rib fractures in adults or transitional adolescents age 18 or older; notifications...
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...
Philips Healthcare (Suzhou) Co., Ltd
The Philips CT 3500 produces CT images of the head and body and is indicated for head, whole-body, cardiac-calcium-scoring, and vascular CT in patients of all ages; it is also...
Aidoc Medical, Ltd.
Chest and abdominal CT triage and notification for suspected vertebral compression fractures in the standard-of-care bone-health workflow; notifications are non-diagnostic and...
AVICENNA.AI
CINA analyzes non-enhanced head CT and head CTA DICOM in parallel with standard interpretation to flag suspected intracranial hemorrhage and anterior-circulation large-vessel...
Viz.ai, Inc.
Notification-only parallel workflow to identify and communicate suspected large vessel occlusion on acute brain CTA to a neurovascular specialist; identification is not for...
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...
Aidoc Medical, Ltd.
Notification-only triage of adult head CTA for suspected complete large-vessel and medium-vessel occlusions; compressed previews are informational and the full study remains...
Aidoc Medical, Ltd.
BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of CT exams with contrast (CTA and CT with contrast) that include the...
Canon Medical Systems Corporation
Aquilion Precision TSX-304A/4 V10.10 with AiCE is a CT system for cross-sectional imaging of the labeled abdomen, pelvis, chest, cardiac, extremity, and head examinations,...
iSchemaView Inc.
Assist hospital networks and trained radiologists with workflow triage by flagging and communicating suspected IPH, IVH, SAH, and SDH findings in non-enhanced head CT images.
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...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images in adults or transitional adolescents aged 18 and...
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...
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-...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on the Discovery CT750 HD...
Viz.ai, Inc.
Viz SDH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist,...
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,...
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,...
Canon Medical Systems Corporation
Aquilion ONE with Vitrea VSTP-001A provides whole-body CT acquisition and reconstruction with labeled FIRST, AiCE, spectral, cardiac, vascular, pulmonary, neurologic, abdominal,...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images in adults or transitional adolescents aged 18 and...
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.
iSchemaView Inc.
Rapid PE Triage and Notification (PETN) is a radiological computer aided triage and notification software indicated for use in the analysis of CTPA images. The device is intended...
Siemens Medical Solutions USA, Inc.
syngo.CT CaScoring is an image analysis software package for evaluating CT data sets. The software is designed to support the physician in evaluating and documenting calcified...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images in adults or transitional adolescents...
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT provides head, whole-body, cardiac, and vascular CT imaging for patients of all ages and can support qualified low-dose lung screening under labeled programs...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in...
NanoxAI Ltd.
Qualitative and quantitative spine analysis from CT images to support clinician evaluation of musculoskeletal spinal disease, including vertebral labeling, vertebral height-loss...
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...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CT Angio (CTA) images. The device is intended to assist...
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...
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...
Viz.ai, Inc.
Viz ANEURYSM (Viz ANX) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital...
GE Medical Systems, LLC.
TrueFidelity deep-learning CT reconstruction supports head, whole-body, cardiac, and vascular imaging on specified Revolution CT configurations with release-specific speed and...
GE Healthcare Japan Corporation
Revolution Ascend produces axial, cine, helical, cardiac, and gated CT images from X-ray transmission data with or without contrast, with post-processing and analysis for head,...
Siemens Medical Solutions USA, Inc.
Intracranial hemorrhage on non-contrast CT examinations of the head. It makes case-level output available to a CT scanner or other PACS system for worklist prioritization. The...
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,...
Philips Medical Systems Nederland, B.V.
Precise Image is an adult head-and-body CT reconstruction application for selected Philips Incisive CT protocols that uses a convolutional neural network to reduce noise and...
AIbolit Technologies, LLC
AIBOLIT 3D+ processes, reviews, analyzes, communicates, and interchanges multidimensional digital images acquired from CT to support preoperative surgical planning, training,...
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...
Circle Neurovascular Imaging, Inc
Stroke SENS LVO is a radiological computer-aided triage and notification (CADt) software indicated for use in the analysis of CTA head images. The device is intended to assist...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution Ascend.
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...
Canon Medical Systems Corporation
Aquilion Exceed LB is a CT system for cross-sectional imaging of the labeled body regions and examinations described in K211828, with professional review of acquired and...
Infervision Medical Technology Co., Ltd.
InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of Non-Enhanced Head CT images. The device is intended to assist...
Shanghai United Imaging Healthcare Co., Ltd.
uCT ATLAS with uWS-CT-Dual Energy Analysis supports the labeled CT acquisition, reconstruction, and dual-energy image-analysis workflow for professional interpretation.
Qure.ai Technologies
Automatic labeling, visualization, and quantification of segmentable brain structures from non-contrast head CT, including intracranial hyperdensities, lateral ventricles, and...
ClariPi Inc.
ClariCT.AI receives, processes, and enhances supported CT DICOM images regardless of the labeled CT manufacturer or model for professional review within the cleared workflow.
Nico.Lab B.V.
HALO is a notification only cloud-based image processing software application using artificial intelligence algorithms to analyze patient imaging data in parallel to the standard...
Philips Healthcare (Suzhou) Co., Ltd.
Precise Position uses a ceiling-mounted color and depth camera with a convolutional neural network to assist positioning patients aged 16 years and older on Philips Incisive CT by...
Avicenna.AI
Radiological computer-aided triage and notification for chest CTA suspected pulmonary embolism and chest or thoraco-abdominal CTA suspected aortic dissection, assisting hospital...
Genesis Software Innovations
The Preview Shoulder software is intended to be used as a tool for orthopedic surgeons to develop pre-operative shoulder plans based on a patient CT imaging study. The import...
Aidoc Medical, Ltd.
Parallel triage and notification of suspect cases with three or more acute rib-fracture pathologies to assist hospital-network workflow prioritization; not a diagnostic device.
Siemens Healthcare GmbH
Adjunctive CAD assistance to alert radiologists to regions of interest that may otherwise be overlooked during chest MDCT review; concurrent first-reader or second-reader use is...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation, including...
Viz.ai, Inc.
Notification-only, parallel workflow tool for hospital networks and trained clinicians that analyzes acute non-contrast brain CT and communicates suspected intracranial hemorrhage...
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...
Optellum Ltd
Virtual Nodule Clinic (VNC) is a software device used in the tracking, assessment and characterization of incidentally detected pulmonary nodules. VNC includes a computer-aided...
GE Medical Systems, LLC.
MaxFOV 2 is a deep-learning CT image reconstruction method for head and whole-body axial, helical, and cine acquisitions. It extends the nominal display field of view when patient...
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...
Shanghai United Imaging Intelligence Co., Ltd.
uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. The device is intended to assist hospital networks...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head. Volume sets may be used for specialized studies by a trained and...
Aidoc Medical, Ltd.
BriefCase analyzes supported noncontrast head CT, head CTA, noncontrast cervical-spine CT, and CTPA examinations to triage suspected intracranial hemorrhage, large-vessel...
GE Medical Systems, LLC
The Deep Learning Image Reconstruction for Gemstone Spectral Imaging option is a deep learning based CT reconstruction method intended to produce cross-sectional images by...
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head. Volume sets may be used for specialized studies by a trained and...
NICo-Lab B.V.
HALO analyzes contrast-enhanced brain CTA in the acute setting for suspected anterior-circulation large-vessel occlusion and provides notification support for emergency stroke...
GE Healthcare Japan Corporation
Revolution Ascend is a diagnostic CT system for acquisition, reconstruction, display, and professional interpretation in the labeled scanner and protocol workflow.
GE Medical Systems SCS
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended 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...
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...
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,...
Aidoc Medical, Ltd.
BriefCase analyzes contrast-enhanced chest CT for suspected pulmonary embolism and notifies or prioritizes the study in the labeled hospital or cloud worklist workflow; the output...
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....
MaxQ Al Ltd.
AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial...
iSchemaView Inc.
Notification-only triage of adult head CTA for suspected large-vessel occlusion; results do not replace diagnostic interpretation.
Shanghai United Imaging Healthcare Co., Ltd.
Deep Recon is a data-driven deep-learning CT reconstruction method for axial, helical, and cardiac acquisitions. It is designed to generate lower-noise CT images, improve...
Beijing Infervision Technology Co.,Ltd.
Computer-assisted reading aid for radiologists detecting pulmonary nodules during review of chest CT examinations in an asymptomatic population; both lungs must be in the field of...
iSchemaView Inc.
Adjunct evaluation of extent of early ischemic brain injury in patients with known MCA or ICA occlusion during stroke imaging interpretation within 6 hours
AVICENNA.AI
CINA analyzes nonenhanced head CT for suspected intracranial hemorrhage and head CTA for suspected large-vessel occlusion for computer-aided triage and notification in parallel...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital...
Qure.ai Technologies
qER is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT images. The device is intended to assist hospital...
Siemens Medical Solutions USA, Inc.
syngo.CT CaScoring analyzes noncontrast standard- or low-dose cardiac CT, marks calcified coronary lesions, allocates them to the right coronary, left main, left anterior...
Zebra Medical Vision Ltd.
Passive, prioritization-only, parallel-workflow notification for clinicians in bone-health settings to prioritize chest and abdominal CT cases suggestive of at least one vertebral...
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...
Nines, Inc.
NinesAI is a parallel workflow tool indicated for use by hospital networks and trained clinicians to identify images of specific patients to a radiologist, independent of standard...
CuraCloud Corp.
CuraRad-ICH is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial...
iSchemaView Incorporated
Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage; results do not replace diagnostic interpretation.
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...
Viz.ai, Inc.
Notification-only triage of adult noncontrast head CT for suspected intracranial hemorrhage, with specialist notification; results do not replace diagnostic interpretation.
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...
Siemens Medical Solutions, Inc
Adjunctive CAD assistance to alert radiologists to potentially overlooked solid pulmonary nodules during chest MDCT review; second-reader use only after the radiologist's initial...
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...
Icometrix NV
icobrain ctp provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes...
Canon Medical Systems Corporation
Aquilion Prime SP with AiCE-i supports the labeled CT acquisition, reconstruction, visualization, and professional-interpretation workflow for the cleared scanner configuration.
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation, including...
GE Hangwei Medical Systems, Co., Ltd.
Auto Positioning uses 3D patient-position information and the selected CT protocol to suggest scout range, orientation, table height, and collision checks before a...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images. The device is intended to assist hospital...
Siemens Medical Solutions USA, Inc.
syngo.CT CaScoring analyzes noncontrast cardiac CT, marks and allocates calcified coronary lesions to the right coronary, left main, left anterior descending, or circumflex...
GE Healthcare Japan Corporation
TrueFidelity deep-learning CT reconstruction produces selectable-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution EVO.
Cleerly Inc
Cleerly Labs provides interactive cardiac CT or CCTA analysis for the presence and extent of coronary plaque, atherosclerosis, and stenosis in coronary artery disease or suspected...
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...
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...
Deep01 Limited
Notification-only, parallel-workflow triage that identifies and communicates acute non-contrast brain CT studies with suspected ICH to a specialist for image review; not for...
Canon Medical Systems Corporation
Aquilion Precision V8.8 is an ultra-high-resolution whole-body CT system; its AiCE deep-convolutional reconstruction is limited in this clearance to abdomen and pelvis...
ClariPI Inc.
ClariCT.AI assists radiologists and specialists by denoising and enhancing DICOM CT images of the head, chest, heart, and abdomen, including low-dose filtered-back-projection and...
Zebra Medical Vision Ltd.
Case-level triage of adult non-contrast head CT examinations with features suggestive of intracranial hemorrhage (ICH); not a diagnostic or rule-out tool.
Canon Medical Systems Corporation
The device is indicated to acquire and display cross-sectional volumes of the whole body, including the head, with capability to image whole organs in a single rotation. Volume...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine on CT images. The device is intended to assist...
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...
Aidoc Medical, Ltd.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced CT and CTPA images. The device is intended to assist...
GE Medical Systems, LLC.
TrueFidelity deep-learning CT reconstruction produces low, medium, or high-strength images for supported head, whole-body, cardiac, and vascular applications on Revolution CT.
GE Medical Systems SCS
Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by...
Elucid Bioimaging Inc.
vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...
Vital Images, Inc.
Vitrea CT Brain Perfusion is a noninvasive post-processing software that calculates cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e., delay of...
MaxQ-Al Ltd.
Accipiolx prioritizes adult noncontrast head CT studies for cases with acute intracranial hemorrhage by sending studies from PACS to an analysis engine and returning case-level...
Aidoc Medical, Ltd.
BriefCase provides computer-assisted triage and notification for suspected intracranial hemorrhage on noncontrast head CT and or large-vessel occlusion on head CTA in parallel...
Zebra Medical Vision Ltd.
The HealthCCS Device is intended for use as a non-invasive post-processing software that can be used to evaluate calcified plaques in the coronary arteries, which may be a risk...
Thirona Corporation
Provide quantitative support for physician diagnosis, follow-up examination, and documentation of pulmonary-tissue images or abnormalities from CT thoracic datasets.
Viz.ai, Inc.
Image processing, analysis, and communication of dynamic brain CT perfusion datasets to calculate perfusion parameters for review by trained professionals.
Viz.Al, Inc.
ContaCT is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist,...
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...
ALGOMEDICA
PixelShine is intended for networking, communication, processing, and enhancement of CT images in DICOM format to assist professional radiologists and specialists in reaching...
RIVERAIN TECHNOLOGIES, LLC
ClearRead CT is a post-processing adjunct for detecting pulmonary nodules on chest CT in an asymptomatic population; it generates a secondary vessel-suppressed lung CT with CADe...
IMBIO LLC
Quantitative support for physician diagnosis, documentation, and follow-up examination of pulmonary tissue images and abnormalities from CT thoracic datasets
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...