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...
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:...
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,...
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...
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
FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....
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...
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...
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
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
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...
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...
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...
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
FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.
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...
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,...
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...
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
FDA product code PCS identifies this device class as Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox. Intended for diagnostic use to present images that...
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...
GE Medical Systems SCS
FDA product code LLZ identifies this device class as System, Image Processing, Radiological. Consult the linked FDA record for the exact authorized indications for use.
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,...
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.
FDA product code LNH identifies this device class as System, Nuclear Magnetic Resonance Imaging. Consult the linked FDA record for the exact authorized indications for use.
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...
GE Medical Systems SCS
FDA product code JAK identifies this device class as System, X-Ray, Tomography, Computed. Consult the linked FDA record for the exact authorized indications for use.
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...
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,...
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.
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...