Use case
A buyer-oriented shortlist for oncology quantification. Confirm exact intended use and local validation needs before any pilot or procurement decision.
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...
HistoSonics, Inc.
HistoSonics Planning Tool is a stand-alone visualization and comparison tool for CT and MR studies used to plan histotripsy target localization, treatment volume, acoustic path,...
Aitewan Biomedical Technology, Inc.
DeepBT Detector-Plus provides initial gross-tumor-volume contours on T1-weighted contrast-enhanced and optional T2-weighted MR images for radiation-treatment planning in adults...
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...
Varian Medical Systems, Inc.
syngo.via RT Image Suite VC10 provides three-dimensional and four-dimensional multimodality visualization, registration, fusion, contouring, and planning support for...
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...
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...
Ultrasound AI
Delivery Date AI analyzes obstetric ultrasound images to provide a predicted delivery date for singleton pregnancies in women age 18 or older at 14 0/7 through 36 6/7 weeks when...
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...
Elekta Solutions AB
The EMLA family delivers external-beam radiation therapy for adult and pediatric patients with benign, malignant, or metastatic disease. Authorized techniques vary by model:...
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...
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.
Techsomed Medical Technologies
BioTraceIO Vision V1.7 processes CT and MR images to support ablation target and needle planning and zone confirmation for the labeled liver and kidney workflows.
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panvivo and Panvivo S acquire and display PET and CT information for anatomical and functional imaging, radiopharmaceutical distribution, and the labeled oncology, cardiology,...
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...
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;...
Taiwan Medical Imaging Co., Ltd.
TAIMedImg DeepMets assists trained professionals by providing initial gross-tumor-volume contours on axial contrast-enhanced T1 brain MR images for radiation-treatment planning in...
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,...
RaySearch Laboratories AB (PUBL)
RayStation and RayPlan releases covered by K240398 are configurable radiotherapy and medical-oncology software that proposes or supports treatment plans from user inputs, with...
OncoSoft. Co., Ltd.
OncoStudio OS-01 creates initial deep-learning organs-at-risk contours from CT images of the head and neck, thorax, abdomen, and pelvis for radiation-oncology review, editing, and...
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...
Shanghai United Imaging Healthcare Co.,Ltd.
The uMI Panvivo PET/CT system provides anatomical and functional images. PET depicts the distribution of approved radiopharmaceuticals and CT provides diagnostic tomographic and...
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...
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...
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...
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....
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...
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...
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...
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...
Siemens Medical Solutions USA, Inc.
syngo.via RT Image Suite VB80 supports trained radiation-oncology professionals with multimodality visualization, registration, advanced contouring, treatment preparation,...
Techsomed
VisAble.IO is CT and MR image-processing software for liver-ablation procedures. It imports images from CT and MR scanners and facility PACS systems, assists physicians with...
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...
MRIguidance B.V
MRI-based BoneMRI image enhancement for visualizing pelvic and cervical, thoracic, lumbar and S1 spinal bone structures with CT-like radiodensity contrast; not for tumor diagnosis...
Quanta Computer Inc.
QOCA image Smart RT Contouring System automatically contours DICOM CT imaging data using deep-learning algorithms. Generated contours may be used as input to external-beam...
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...
Siemens Medical Solutions USA, Inc.
The Biograph VK10 combines X-ray CT and PET to register and fuse anatomic and physiologic information, supports independent CT or PET imaging, and aids trained professionals in...
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...
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...
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...
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...
Ever Fortune.AI Co., Ltd.
EFAI HCAPSeg assists trained radiation-oncology professionals with radiation-treatment planning by providing initial deep-learning contours of organs at risk on non-contrast CT...
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...
Siemens Medical Solutions USA, Inc.
The Biograph Vision.X and Biograph Vision.X Edge combine X-ray CT and PET to register and fuse anatomic and physiologic information, support independent CT or PET imaging, aid...
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...
GE Healthcare
Precision DL uses deep-learning image processing to enhance non-time-of-flight F-18 FDG PET images for clinical oncology review in adults and children.
Sonic Incytes
Velacur Sonic measures liver tissue stiffness and ultrasound attenuation to aid clinical management of liver disease within the labeled workflow.
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...
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 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...
MRIguidance B.V.
MRI-based BoneMRI v1.6 image enhancement for visualizing pelvic and L3-S1 lumbar bone structures with enhanced contrast; not for tumor diagnosis or monitoring and not a CT...
MRlguidance B.V.
BoneMRI enhances bone contrast in dedicated MRI examinations of the pelvic sacrum, hip bones, femoral heads, and lumbar spine from L3 through S1; it is not intended to diagnose or...
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...
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...
Spectronic Medical AB
MRI Planner creates synthetic CT images for photon external-beam radiation planning from MRI and can generate healthy-structure contours for specified brain, head-and-neck, and...
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...
TeraRecon, Inc
The TeraRecon Neuro algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians. The TeraRecon Neuro...
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)...
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,...
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...
Philips Oy
Generation of MR-derived, CT-like density images for radiotherapy planning and patient-positioning workflows in patients with soft-tissue tumors of the head and neck.
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...
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,...
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...
MRIguidance B.V
BoneMRI enhances bone contrast in pelvic MRI examinations of the sacrum, hip bones, and femoral heads; it is not intended to diagnose or monitor primary or metastatic tumors 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...
GE Medical Systems SCS
FlightPlan for Liver is a post processing software package that helps the analysis of 3D x-ray angiography images of the liver. Its output is intended as an adjunct means to help...
Philips Medical Systems Nederland B.V.
Vereos PET/CT detects, localizes, diagnoses, stages, restages, and follows treatment response in oncology, cardiology, and neurology and can provide diagnostic CT and...
Siemens Medical Solutions USA Inc.
syngo.via RT Image Suite VB60 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, treatment preparation, DICOM export,...
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...
RaySearch Laboratories AB (publ)
RayStation 10.1 is configurable radiation-treatment planning software for radiation therapy and medical oncology that supports treatment-plan proposal, review, approval, and...
Vysioneer Inc.
VBrain assists trained professionals in radiation-treatment planning by providing initial contours of known or diagnosed brain tumors on axial contrast-enhanced T1 brain MR images...
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...
AI Metrics, LLC
AI Metrics supports viewing, manipulation, communication, storage, annotation, analysis, and comparison of medical images and anatomical datasets across modalities and timepoints...
Resonance Health Analysis Services Pty Ltd
HepaFat-AI assesses volumetric liver fat fraction, proton-density fat fraction, and steatosis grade in confirmed or suspected fatty-liver disease, supports monitoring of liver fat...
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,...
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...
Limbus AI Inc.
Limbus Contour assists trained radiation oncologists, dosimetrists, and physicists by generating CT and MR anatomical contours for review and DICOM RT Structure Set transfer into...
Siemens Medical Solutions USA, Inc.
syngo.via RT Image Suite VB50 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, simple treatment preparation, and DICOM...
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
Biograph Vision and Biograph mCT are combined PET/CT systems for acquiring, reconstructing, fusing, displaying, evaluating, and archiving PET and CT studies across labeled...
Varian Medical Systems, Inc.
Ethos Treatment Management is indicated for managing and monitoring radiation-therapy treatment plans and sessions. Ethos Treatment Planning is indicated for generating and...
Philips Medical Systems MR Finland
Generation of MR-derived attenuation information for photon radiotherapy planning of primary and metastatic brain tumors.
Siemens Medical Solutions USA, Inc.
syngo.via RT Image Suite VB40 supports trained radiation-oncology professionals with multimodality visualization, registration, contouring, simple treatment preparation, DICOM...
RaySearch Laboratories AB (publ)
RayCare is an oncology information system used to support workflows, scheduling, and clinical information management for oncology care and follow-up. It may transfer, store,...
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,...
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...
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...
Resonance Health Analysis Services Pty Ltd
FerriSmart analyzes magnetic resonance images to estimate liver iron concentration for clinician review.
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...
Arterys Inc.
Oncology imaging workflow for viewing, manipulating, 3D visualizing, and comparing images and assessing/documenting morphological changes at diagnostic and therapy follow-up;...
Microsoft Corp.
Microsoft Radiomics App v1.0 is a software-only medical device for trained radiation oncologists, dosimetrists, and physicists to derive organ and tumor contours for...
Siemens Medical Solutions, USA, Inc.
syngo Application Software provides real-time viewing, image manipulation, 3D visualization, communication, and storage of medical images and data on exchange media for diagnostic...
Cydar Ltd.
Cydar EV provides image guidance by overlaying preoperative 3D vessel anatomy from a previously acquired contrast-enhanced diagnostic CT scan onto live fluoroscopic images to...
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...