Use case
A buyer-oriented shortlist for quantification and segmentation. Confirm exact intended use and local validation needs before any pilot or procurement decision.
Agada Medical, Ltd.
Auto-Seg and Spine Auto-Seg accept spine and pelvis CT images and provide three-dimensional segmentation and labels to support spine-surgery planning and assessment by spine...
Adas3D Medical S.L.
ADAS 3D supports visualization and analysis of MR and CT images of the heart for individual patients with cardiovascular disease, including patients with myocardial scar from...
Cercare Medical A/S
Cercare Neurosuite with Capillary Function and Oncology Virtual Expert processes CT or MR information to provide perfusion, tissue-blood-volume, diffusion, labeling, and...
FUJIFILM Healthcare Americas Corporation
Synapse PACS 7.6.0 provides medical-image management and processing, including measurements, regional segmentation, clinical calculations, structured reports, comparison, fusion,...
Brainomix Limited
Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
Mighty Oak Medical
Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional...
Keya Medical Technology Co., Ltd.
Coronary plaque and stenosis quantification from CCTA
Imeka Solutions, Inc.
ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained...
Neurophet., Inc.
Brain MRI/PET registration, segmentation and quantitative PET assessment
Neurophet., Inc.
Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric...
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative...
BeauBrain Healthcare, Inc.
Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it...
Fujifilm Corporation
Fujifilm Synapse 3D Base Tools V7.2 provides trained professionals with two-dimensional, three-dimensional, multiplanar, and related viewing, measurement, and analysis functions...
ABBOTT MEDICAL
Abbott OPTIS Mobile or Integrated Next with Ultreon 3.0 processes compatible coronary intravascular OCT data to support visualization, measurement, and interventional assessment...
Dentsply Sirona
DS Core CBCT Anatomy uses CBCT and digital-impression data to provide tooth and jaw segmentation, inferior-alveolar-nerve-canal segmentation, panoramic-curve support, and...
Edgecare, Inc.
EdgeFlow UW20 is a wearable ultrasound system for noninvasive periodic bladder-volume measurement in adults with BMI no greater than 30.
Mim Software, Inc.
Contour ProtégéAI+ processes CT and MR DICOM images and generates contours for quantitative analysis, adaptive therapy, image registration, transfer to radiotherapy planning, and...
Voronoi Health Analytics Incorporated
DAFS automatically segments anatomy on DICOM Part 10 CT images and supports reviewed two- and three-dimensional visualization, editing, and area, volume, and intensity...
Beijing Infervision Healthcare Medical Technology Co., Ltd.
InferCare RECIST is a post-processing application for longitudinal medical-image display, lesion measurement, registration, tracking, segmentation, three-dimensional...
Perspectum, Ltd.
LiverMultiScan v6.0 is MR diagnostic software for non-invasive liver-health assessment that generates, displays, and supports review of MR data and quantitative cT1, PDFF, and LIC...
Depuy Ireland UC
VELYS Hip Navigation analyzes intraoperative X-ray or fluoroscopy for total hip arthroplasty with surgeon-confirmed landmark suggestions and measurements of cup orientation, leg...
Orca Dental AI, Ltd.
CEPHX3D processes dental and craniomaxillofacial images to support diagnosis and treatment planning, including three-dimensional models, viewing, segmentation, measurements, and...
Exo Imaging
Provides AI-assisted cardiac, lung and abdominal quality feedback and measurements; users remain responsible for scan quality and diagnosis and must not rely solely on the...
Cara Medical, Ltd.
CARA assists adult structural-heart and conduction-system procedure planning by segmenting preprocedural CT, visualizing cardiac chambers and conduction landmarks, and overlaying...
Ai4medimaging Medical Solutions S.A.
Cardiac MRI ventricular function and 2D phase-contrast flow quantification
Siemens Medical Solutions USA, Inc.
MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images across one or more time...
Median Technologies
eyonis LCS is a concurrent-reading aid for radiologists that detects, localizes, and characterizes 4-30 mm solid and part-solid pulmonary nodules on low-dose chest CT images for...
Medicalvr B.V.
Surgical Reality Viewer provides preoperative and intraoperative two-dimensional and three-dimensional visualizations from patient images and normal-anatomy segmentations;...
Neurophet., Inc.
Quantitative brain MRI and amyloid-PET analysis, including volumetric reference-percentile comparison and SUVR quantification, to support physician clinical evaluation.
Manteia Technologies Co., Ltd.
AccuContour 4.0 uses deep-learning contours to support segmentation of organs at risk on CT images for radiation-treatment planning, evaluation, and adaptation; qualified...
Siemens Healthcare GmbH
Brain MRI morphometry and white matter hyperintensity quantification, including normative comparison and longitudinal change assessment for clinician review.
Philips Medical Systems Nederland B.V.
AV Vascular assists trained healthcare professionals with visualization, assessment, and quantification of vascular anatomy on CTA and/or MRA for suspected or diagnosed vascular...
Softlink International Private Limited
Imagine Enterprise Suite receives, stores, shares, visualizes, quantifies, and processes images from multiple modalities; MPXA-2000 supports coronary-angiography calculation with...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and...
HeartLung Corporation
AI-CVD provides automated quantitative CT-derived anatomical and density measurements for clinician review, including calcium scores, cardiac and vascular measurements, lung and...
Ultrasight, Ltd.
PVAD IQ supports qualified-physician clinical decision support by identifying the aortic annulus and PVAD inlet, calculating their mean distance, and identifying clips acceptable...
Neosoma, Inc.
Neosoma Brain Mets semi-automatically segments and contours previously diagnosed brain metastases on T1 post-contrast brain MRI to support radiation-oncology treatment planning.
Intuitive Surgical, Inc.
IRISeg accepts MR or contrast-enhanced CT images for manual and machine-learning image analysis and segmentation and produces visual three-dimensional models for preoperative...
Overjet, Inc.
Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support
Mighty Oak Medical
Acorn 3D Software provides modular image processing, visualization, segmentation, measurement, treatment planning, and three-dimensional-printing support; Acorn Trajectory...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and...
Pie Medical Imaging BV
3mensio Workstation is standalone medical-image analysis software for advanced visualization and quantitative analysis of cardiovascular structures. It supports CT, X-ray...
Mighty Oak Medical
Acorn 3D Software with Acorn 3DP Model provides modular image processing, visualization, segmentation, measurements, treatment planning, and three-dimensional models, including...
ViTAA Medical Solutions, Inc.
AiORTA Plan analyzes cardiovascular CT angiography data to provide volumetric visualization and measurements as adjunctive information for licensed healthcare professionals; it is...
Siemens Healthineers AG
Syngo Carbon Clinicals VA41 provides advanced visualization and analysis for clinical images, including OrthoMatic Spine whole-spine curve-angle measurements and TimeLens...
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.
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...
Quantib BV
Brain WMH automatically labels, visualizes, and volumetrically quantifies white-matter hyperintensities from T2w FLAIR brain MR and returns segmentations, overlays, and...
Axial Medical Printing Limited
Axial3D Insight is a cloud-based image-segmentation service that transfers DICOM images to generate visual models and physical-replica inputs for trauma, orthopedic,...
Diagnoly
FETOLY analyzes fetal ultrasound images and sequences to detect labeled fetal brain and heart views, assess image completeness or quality, and provide fetal biometric measurements...
DGNCT, LLC
Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating...
Nurea
PRAEVAorta 2 assists clinical specialists, physicians, and other licensed practitioners with automatic vascular segmentation and maximum-diameter measurement on adult CT images;...
EOS imaging
VEA Align is cloud-based software for orthopedic applications in adult and pediatric populations using two-dimensional X-ray images from EOS imaging systems to display interactive...
Medicrea International S.A.S. (Medtronic)
UNiD Spine Analyzer assists healthcare professionals in viewing and measuring images and planning orthopedic spine surgery, including preoperative and postoperative measurements,...
GE Medical Systems Ultrasound and Primary care Diagnostics
Venue, Venue Go, Venue Fit, and Venue Sprint are general-purpose point-of-care ultrasound systems for trained users across broad adult, pediatric, and neonatal applications, with...
Peek Health, S.A.
PeekMed is a cloud web system for preoperative orthopedic planning from imported X-ray, CT, and MR images, with two-dimensional and three-dimensional visualization, measurements,...
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...
FUJIFILM Healthcare Americas Corporation
Synapse PACS version 7.5 provides primary processing and presentation of DICOM and supported non-DICOM images with measurement, segmentation, fusion, volume rendering, reporting,...
GE Medical Systems Israel
Aurora is a SPECT/CT system for nuclear-medicine uptake imaging, standalone CT, anatomical localization, attenuation correction, diagnosis, staging, therapy planning, guidance,...
Brainlab Ltd.
TraumaCad Neo assists healthcare professionals in analyzing orthopedic conditions and planning orthopedic procedures by overlaying measurements and prosthesis templates on...
Audax d.o.o.
AudaxCeph Cephalogram Analysis Software assists specialized dental practices with storing and presenting patient cephalogram images and treatment planning through landmark...
GE Medical Systems Ultrasound and Primary care Diagnostics
Voluson Performance 16 and 18 are general-purpose diagnostic ultrasound systems for imaging, measurement, display, and analysis of the human body and fluid across the labeled...
iSchemaview Inc.
Brain midline-shift measurement on adult non-contrast CT
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.
Pearl Inc.
Second Opinion BLE identifies and displays bone-level measurements in bitewing and periapical radiographs for dental health professionals reviewing permanent teeth in patients age...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vscan Air is a wireless handheld point-of-care ultrasound system for broad adult, pediatric, and neonatal applications. K250087 adds deep-learning automatic bladder-volume...
GE Medical Systems SCS
VersaViewer supports two-dimensional, three-dimensional, and four-dimensional medical-image series processing and analysis through customizable layouts, multimodality review, and...
LARALAB GmbH
Cardiac CT segmentation, measurement and valve-intervention planning
Clarius Mobile Health Corp.
Clarius Prostate AI provides semi-automatic measurements of prostate volume from ultrasound data acquired by the Clarius Ultrasound Scanner.
CureMetrix, Inc.
cmAngio (V1.6) processes screening mammograms to aid a qualified interpreting physician in the manual process of identifying breast arterial calcification. It detects the presence...
Siemens Healthcare GmbH
syngo Dynamics VA41D is a multimodality, vendor-agnostic cardiology image and information system for management, processing, review, post-processing, and quantification of cardiac...
TribusMed Beheer BV
TribusConnect provides remote viewing and manipulation of CT DICOM data for pre- and post-cardiac-intervention review, including volume rendering, heart segmentation, simulated...
Vent Creativity
Vent Creativity Knee v1.0 (Hermes) assists healthcare professionals in transferring CT imaging into bone segmentation and preoperative orthopedic planning outputs, including...
Avatar Medical
brAIn Shoulder Positioning assists shoulder surgeons with preoperative planning and visualization for primary total shoulder replacement by segmenting shoulder CT data and...
Coreline Soft Co., Ltd.
AVIEW assists physicians with quantitative CT analysis of thoracic and cardiac datasets, including lung, lobe, airway, fissure, nodule, coronary calcium, density, measurement, and...
Peek Health, S.A.
PeekMed web supports preoperative planning from imported patient imaging with two-dimensional and three-dimensional visualization, measurements, templates, and procedure planning;...
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.
Phantomics Inc.
Myomics assists qualified medical professionals with viewing, post-processing and qualitative/quantitative evaluation of 3T cardiovascular MR images in DICOM format, including...
Fovia, Inc.
aiCockpit AI Viewer displays DICOM and AI images with annotations, measurements, three-dimensional reformats, and reports for trained healthcare professionals; the physician...
Philips Ultrasound LLC
Ultrasound Workspace reviews, quantifies, and reports structures and function from multidimensional digital medical data from different modalities in cardiovascular, fetal, and...
Gleamer SAS
BoneMetrics is fully automated software that assists trained radiology professionals with Cobb-angle measurement on frontal spine radiographs in patients aged four years or older...
MIM Software Inc.
Contour ProtégéAI+ automatically creates contours on CT and T2 MR DICOM images as an accessory to MIM software for quantitative analysis, adaptive therapy, transfer, and archive;...
Prenuvo
Prenuvo Body Composition is software that non-invasively quantifies fat, muscle, and organs from compatible MR DICOM datasets and displays internal body information, including...
Ortho AI LLC
Ortho AI measures lengths, angles, and implant position relative to bone on radiographic images for total hip arthroplasty, total knee arthroplasty, and lumbar-spine fusion...
Orthofix Srl
The OrthoNext Platform System is indicated to assist healthcare professionals in preoperative planning of orthopedic surgery and postoperative planning of orthopedic treatment. It...
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...
Peek Health, S.A.
PeekMed web is designed to help healthcare professionals perform preoperative planning for surgical procedures using imported patient imaging studies. The FDA material describes...
Exo Inc
Measures global longitudinal strain from apical four-chamber cardiac ultrasound images in adult patients with suspected disease as an aid to diagnostic analysis; users can accept...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Versana Premier, Versana Premier Lotus, and LOGIQ F are general-purpose diagnostic ultrasound systems for broad hospital and clinic applications; K242005 adds transesophageal use,...
BodyVision Medical Ltd.
The LungVision System enables users to segment previously acquired 3D CT datasets and overlay and register those segmented datasets with fluoroscopic live X-ray images of the same...
PIUR Imaging GmbH
PIUR tUS Infinity supports a computer-aided thyroid ultrasound workflow that identifies thyroid lobes and margins, calculates volume, marks and quantifies nodules, and provides...
Q Bio, Inc.
Constellation is intended for non-invasive labeling and calculation of quantitative measurements for anatomical regions using whole-body DICOM MR images gathered on a GE MR450W....
Adas3D Medical S.L
ADAS 3D provides visualization, analysis, and quantification of MR and CT heart images in individual patients with cardiovascular disease, including myocardial scar assessment for...
Sonic Incytes
Velacur Sonic measures liver tissue stiffness, ultrasound attenuation, and volume density fat fraction with shear-wave and ultrasound measurements to aid clinical management of...
Shanghai United Imaging Healthcare Co.,Ltd.
uMI Panorama GS combines 148 cm axial-field-of-view PET with CT for qualified healthcare professionals across diagnostic, staging, treatment-planning, and response workflows; this...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows, Scenium, and syngo MBF provide trained healthcare professionals with viewing, manipulation, quantification, analysis, and comparison of PET or...
Siemens Medical Solutions USA, Inc.
MI View&GO is a medical diagnostic application for viewing, manipulating, quantifying, analyzing, and comparing PET, nuclear-medicine, CT, and MR images. The FDA material...
Smart Soft Healthcare
CoLumbo version 3 is an image post-processing and measurement tool that provides quantitative measurements of the lumbar spine from previously acquired lumbar-spine MR images.
Aisap
AISAP CARDIO V1.0 automatically processes and analyzes acquired cardiac POCUS images and produces a report with diagnostic assessment and measurements, including selected valvular...
Hutom Inc.
RUS processes CT images for trained professionals using organ and vessel segmentation, pneumoperitoneum estimation, measurements, paths, and two- or three-dimensional...
Mighty Oak Medical
Acorn Segmentation is intended as an image-segmentation interface for transferring CT or CTA images to an output file, measuring, and treatment planning. The output can be used to...
Disior Ltd
SMART Bun-Yo-Matic X-Ray analyzes foot and ankle X-rays to provide visualizations, measurements, and surgical-planning information for orthopaedic care.
EOS imaging
VEA Align uses 2D X-ray images acquired in EOS imaging systems to display interactive landmarks and support global-alignment assessment, angle and length measurements, and...
Disior Ltd
SMART Bun-Yo-Matic CT analyzes CT images of the foot and ankle to provide three-dimensional visualizations, measurements, and surgical-planning information for orthopaedic care.
Clarius Mobile Health Corp.
Clarius OB AI assists a trained and qualified healthcare professional with measurements of fetal biometric parameters, including head circumference, abdominal circumference, femur...
Surgical Information Sciences, Inc.
SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, GPi, and Vim, and segment implanted leads for surgical review.
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.CT is software for viewing, manipulating, evaluating, and analyzing medical images within healthcare institutions. The FDA indication lists colon visualization, dental...
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...
Eko.ai Pte. Ltd d/b/a Us2.ai
Us2.v2 processes acquired transthoracic cardiac ultrasound images to provide automated estimates and measurements of atrial and ventricular dimensions, volumes, and systolic and...
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...
Edgecare Inc.
EdgeFlow UH10 is an ultrasound device intended to measure urine volume in the bladder noninvasively in professional healthcare facilities such as hospitals and clinics by...
Software Nemotec S.L.
NemoScan supports dental CT or cone-beam CT visualization, segmentation, implant and surgical planning, instrument positioning, and guide planning from preoperative maxillofacial...
iSchemaView, Inc.
Rapid Platform v6.0 is image-processing software for trained professionals that views, processes, and analyzes DICOM images from CT and MRI. It supports functional and dynamic...
EOS imaging
VEA Align is cloud-based orthopedic software that uses 2D frontal and lateral X-ray images acquired in EOS imaging systems to display interactive landmarks and support...
SimBioSys, Inc.
TumorSight Viz analyzes dynamic contrast-enhanced breast MRI for visualization and analysis of biopsy-proven early-stage or locally advanced breast cancer, including registration,...
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MI is software for viewing, processing, evaluating, and analyzing PET, CT, MR, and SPECT images within healthcare institutions, with labeled applications for...
Disior Ltd
Bonelogic 2.2 assists orthopedic healthcare professionals with diagnosis and surgical planning by semi-automatically segmenting bony structures from CT and producing foot and...
GE Medical Systems Ultrasound and Primary care Diagnostics
LOGIQ Totus is a general-purpose diagnostic ultrasound system for trained healthcare professionals to image, measure, display, and analyze the human body and fluid across the...
Circle Cardiovascular Imaging
Myocardial Strain Software Application provides qualitative and quantitative evaluation of cardiovascular MR images, including two-dimensional displacement, velocity, strain,...
Siemens Healthcare GmbH
Syngo Carbon Clinicals provides advanced visualization tools to prepare and process medical images acquired by modalities such as CT and MR for evaluation, manipulation,...
Siemens Medical Solutions USA, Inc.
syngo.via MI Workflows VB80A, Scenium VE60, and syngo MBF VB30 support PET, SPECT, nuclear-medicine, CT, and MR viewing, quantification, analysis, longitudinal comparison, organ...
Exo Inc
Exo AI Platform AIP001 processes imported adult ultrasound DICOM images for lung A-line and B-line assessment and cardiac ejection-fraction measurement and reporting.
Axial Medical Printing Limited
Axial3D Insight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for...
MIM Software Inc.
Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, creates machine-learning contours for quantitative analysis, adaptive...
GE Medical Systems Ultrasound and Primary care Diagnostics
LOGIQ E10 is a general-purpose diagnostic ultrasound system for broad adult and pediatric applications; K231966 adds AI-assisted renal measurements, anatomy-based preset and color...
GE Medical Systems Ultrasound and Primary Care Diagnostic
LOGIQ E10s and LOGIQ Fortis are general-purpose diagnostic ultrasound systems for trained healthcare professionals to image, measure, display, and analyze the human body and fluid...
Carlsmed, Inc.
aprevo Digital Segmentation is software for trained, medically knowledgeable design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy; it...
Siemens Medical Solutions USA, Inc.
The ACUSON Sequoia and Sequoia Select systems provide ultrasound images or signals for the labeled fetal, abdominal, pediatric, neonatal cephalic, small-parts, OB/GYN, cardiac,...
Philips Ultrasound
Lumify is a general-purpose ultrasound system using compatible Android devices and USB transducers; K232500 adds AI-assisted automatic ejection-fraction quantification.
Ontact Health Co., Ltd.
Sonix Health quantifies and reports adult echocardiography by or on the order of a licensed physician using B-mode, M-mode, pulsed-wave Doppler, and continuous-wave Doppler images.
CureMetrix, Inc.
cmAngio processes screening FFDM and DBT mammograms to detect presence or absence of breast arterial calcifications at study and breast level and mark segments for qualified...
Momentum Health Inc.
The Momentum Spine optical-contour-sensing mobile application quantifies asymmetries and assesses body angles and curve progression related to postural asymmetries, including...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panorama combines PET and CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and fused PET/CT images for qualified...
Stryker Corp.
HipCheck assists surgeons with quantitative measurements for femoroacetabular-impingement procedures by processing intraoperative static fluoroscopic images and superimposing...
Orthofix US LLC
The OFIX MIS App assists healthcare professionals in viewing, storing, and measuring images and planning orthopedic surgeries, including measurements for placement of surgical...
In-Med Prognostics L3C
NEUROShield labels, visualizes, and quantifies hippocampal volume from brain MRI as decision support for neurologists and neuroradiologists.
AIRAmed GmbH
AIRAscore automatically labels, visualizes and quantifies segmentable brain structures from MR images, replacing manual volume measurement and providing reference-adjusted reports...
Shanghai United Imaging Healthcare Co., Ltd.
uMI Panorama GS combines 148 cm axial-field-of-view PET with CT to provide quantitative radiopharmaceutical distribution, diagnostic anatomical and attenuation information, and...
Axial Medical Printing Limited
Axial3DInsight is a cloud-based service and image-segmentation framework that transfers DICOM imaging information from a medical scanner to an output file for...
GE Medical Systems Ultrasound & Primary Care Diagnostic, LLC
Voluson SWIFT and Voluson SWIFT+ are general-purpose diagnostic ultrasound systems for qualified and trained healthcare professionals to image, measure, display, and analyze the...
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...
GE Medical Systems, LLC
Auto Segmentation generates initial DICOM RT Structure Set contours for 40 organs or subregions from adult contrast or noncontrast CT across head and neck, thorax, abdomen, and...
Surgical Information Sciences, Inc.
SIS System fuses clinical brain MRI with postoperative CT to visualize DBS anatomy, localize STN, GPe, and GPi, and segment implanted leads for professional review.
Olea Medical
MR DWI/FLAIR Measurement V1.0 processes brain DWI and FLAIR MRI to calculate ADC maps, segment ADC-hypointense regions, and communicate relative or normalized FLAIR measurements;...
Ceevra, Inc.
Ceevra Reveal 3 processes, reviews, analyzes, communicates, and interchanges multidimensional CT and MR images for preoperative planning and intraoperative display, with...
Sonic Incytes
Velacur Sonic measures liver tissue stiffness and ultrasound attenuation to aid clinical management of liver disease within the labeled workflow.
MIM Software Inc.
Contour ProtegeAI assists trained medical professionals with automated processing of CT and MR images, machine-learning contour creation for quantitative analysis, adaptive...
RaySearch Laboratories AB (publ)
RayStation 12A is configurable software for radiation therapy and medical oncology that proposes treatment plans from user input. Authorized users may use reviewed and approved...
Synapsica
RadioLens v1.0 is a medical diagnostic application for displaying, processing, storing, and transferring DICOM data other than mammography, with filtering, digital manipulation,...
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...
Caption Health, Inc
Quantification/measurement
Clarius Mobile Health Corp.
Clarius AI semi-automatically places calipers for non-invasive measurements of musculoskeletal structures on ultrasound data acquired by the Clarius Ultrasound Scanner.
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...
Siemens Medical Solutions USA, Inc.
Syngo Dynamics VA40F is a multimodality, vendor-agnostic cardiology image and information system for medical-image management and processing, with post-processing functions for...
Coreline Soft Co.,Ltd
AVIEW RT ACS is a medical image-management and processing system for radiation-treatment planning with deep-learning auto-segmentation evidence described in the exact FDA decision...
Siemens Medical Solutions USA, Inc.
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...
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 Medical Systems Ultrasound and
Vivid E80, Vivid E90, and Vivid E95 are general-purpose diagnostic ultrasound systems with specialized cardiac applications for imaging, measurement, display, and analysis across...
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,...
Quantib BV
Quantib Prostate versions 1.0 and 2.0 provide processing, visualization, editing, registration, mathematical or statistical analysis, semi-automatic segmentation, volume...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Versana Balance is a general-purpose diagnostic ultrasound system for imaging, measurement, display, and analysis of the human body and body fluids across the labeled fetal,...
Overjet, Inc.
Overjet Caries Assist is a concurrent-read aid for detecting and segmenting caries on bitewing radiographs of permanent dentition in patients aged 18 years and older; it provides...
Medviso AB
Segment 3DPrint reviews and segments images from medical scanners and medical 3D models to generate 3D models for diagnostic visualization, measurement, treatment planning, and...
MVision AI
MVision AI Segmentation automatically generates initial contours from CT images for radiotherapy planning; the contours are transferred for professional visualization, review,...
EXINI Diagnostics AB
aPROMISE X accepts, stores, displays, manipulates, quantifies, and reports digital medical images from nuclear-medicine imaging using PSMA PET/CT, with tools for marking regions...
Ever Fortune.AI Co., Ltd.
EFAI RTSuite CT HN-Segmentation System automatically delineates head-and-neck organs at risk on adult non-contrast CT images to support radiation-treatment workflows; initial...
Siemens Healthcare GmBh
AI-Rad Companion Brain MR VA40 post-processes head MR images to segment and quantify brain structures and white-matter hyperintensities, compare normalized values with healthy...
Carina Medical LLC
INT Contour uses a machine-learning approach to provide initial segmentation and contouring of treatment targets and organs at risk for radiation-treatment planning; qualified...
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...
MIM Software Inc.
Contour ProtégéAI creates machine-learning contours from CT and MR DICOM images to support quantitative analysis, adaptive therapy, radiotherapy planning, archiving, and...
Siemens Medical Solutions USA, Inc.
syngo.CT Extended Functionality provides advanced visualization and processing of CT-acquired or reconstructed data, with labeled trauma, spectral, vascular, pulmonary, oncology,...
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA TTA2.50 analyzes ultrasound to quantify and report cardiovascular, fetal, and abdominal structures and functions, including editable AI-assisted echocardiographic...
Samsung Medison CO., LTD.
Samsung V8 is a general diagnostic ultrasound system for broad hospital, clinic, and practice applications; K211945 adds thoracic scanning, AI-based NerveTrack, and AI-based...
Varian Medical Systems, Inc.
AI Segmentation version 2.0 is a cloud web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review, editing, and...
EXINI Diagnostics AB
aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations...
Siemens Medical Solutions USA, Inc.
syngo.via MI WorkFlows, Scenium, and syngo MBF support the viewing, processing, and quantitative review of supported molecular-imaging and cardiac studies in the exact K211459...
Varian Medical Systems, Inc.
AI Segmentation version 1.0 is a static, cloud-hosted web application that generates initial CT organ-at-risk contours for head and neck, thorax, abdomen, and pelvis for review...
Circle Cardiovascular Imaging Inc.
TruPlan provides CT image processing, visualization, measurements, and cardiac procedure-planning workflow support for the labeled use; exact procedure scope and outputs are...
Fujifilm Corporation
Synapse 3D Base Tools is medical-imaging software that provides trained medical professionals tools to aid reading, interpreting, reporting, and treatment planning. It accepts...
DiA Imaging Analysis Ltd
LVivo Software Application non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients...
Hyperfine Research, Inc
BrainInsight automatically labels, spatially measures, and volumetrically quantifies brain structures from low-field MR images, returning annotated or segmented images, color...
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,...
Quantib BV
Quantib Prostate is image post-processing software for processing, visualizing, and editing prostate MRI images. It supports registered multiparametric-MRI viewing, optional...
Perspectum LTD
LiverMultiScan LMSv4 processes abdominal MRI, including liver images, to generate pixel maps and measurements for proton-density fat fraction, T2 star, and corrected T1, with...
DiA Imaging Analysis Ltd
LVivo Seamless non-invasively processes ultrasound images to detect, measure, and calculate relevant medical parameters of patient structures and function in patients with...
GE Healthcare
Xeleris V is intended for nuclear-medicine or radiology practitioners and referring physicians to display, process, archive, print, report, and network nuclear-medicine data from...
GE Medical Systems Ultrasound and Primary Care Diagnostics
Vivid T8 and Vivid T9 are general-purpose ultrasound systems specialized for cardiac imaging and intended for qualified and trained healthcare professionals for ultrasound...
Coreline Soft Co., Ltd
AVIEW provides CT values for pulmonary tissue from thoracic and cardiac CT datasets and supports quantitative diagnosis, follow-up evaluation, and documentation through lung,...
TOMTEC Imaging Systems GmbH
TOMTEC-ARENA quantifies and reports cardiovascular, fetal, and abdominal structures and functions from supported clinical images and can exchange data with IMAGE-ARENA and...
GE Medical Systems Ultrasound and
Vivid E80, E90, and E95 are cardiovascular and general diagnostic ultrasound systems; K200743 adds AI-assisted cardiac measurements and Doppler-spectrum recognition, expanded...
Caption Health
Caption Interpretation Automated Ejection Fraction Software processes previously acquired adult transthoracic cardiac ultrasound images, stores and manipulates images, and...
Ezra AI Inc.
Ezra Plexo Software is a medical diagnostic application for viewing, manipulation, three-dimensional visualization, and comparison of MR medical images. It supports an oncologic...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Engine is a software platform that provides basic visualization and enables external post-processing extensions for medical images used for diagnostic purposes....
MIM Software Inc.
Contour ProtegeAI is used by trained medical professionals as a tool for automated processing of CT and MR medical images. It creates contours with machine-learning algorithms for...
DiA Imaging Analysis Ltd
LVivo Software Application processes ultrasound clips and supports the labeled LVivo EF, SG, SAX, RV, and Bladder measurements and analyses, with user review and editing of...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Brain MR post-processes typical head-MR T1 MPRAGE images to automatically segment and quantify brain structures, compare normalized volumes with healthy reference...
Philips Healthcare
QLAB Advanced Quantification Software is a software application package designed to view and quantify image data acquired on Philips ultrasound systems.
Coreline Soft Co., Ltd
AVIEW LCS reviews and analyzes thoracic CT images to characterize lung nodules in a single study or over time, including nodule measurements and release-specific Lung-RADS...
Philips Ultrasound, Inc.
The K201012 labeling covers Philips EPIQ, Affiniti, CX50, Sparq, and Lumify diagnostic ultrasound systems plus QLAB image viewing and quantification across labeled adult,...
Galgo Medical S.L
ADAS 3D post-processes contrast cardiac MRI and CTA to visualize and quantify myocardial scar and export reviewed results to electrophysiology navigation systems; it is not...
Philips Healthcare
QLAB Advanced Quantification Software views and quantifies image data acquired on Philips ultrasound systems for professional review, including supported three-dimensional cardiac...
Software Nemotec S.L.
NemoScan supports dental implantology by segmenting and transferring anatomy from CT or cone-beam CT images for implant and surgical planning.
Ultromics Ltd
EchoGo Core automatically measures ejection fraction, global longitudinal strain, and left-ventricular volume from echocardiograms and reports the measurements to a clinician...
MEDICALIP Co., Ltd
MEDIP PRO is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and for preoperative treatment...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Cardiovascular processes previously acquired CT DICOM studies to support quantitative and qualitative cardiovascular analysis, including heart segmentation and...
3D Systems, Inc.
D2P is a software interface and image-segmentation system for transferring DICOM imaging information from a medical scanner to an output file and is also preoperative software for...
EXINI Diagnostics AB
aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained...
Siemens Medical Solutions USA, Inc.
AI-Rad Companion Pulmonary processes CT DICOM studies to support lung and lobe segmentation, measurements, density thresholds, and pulmonary-lesion segmentation, measurement, and...
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,...
AmCad BioMed Corporation
AmCAD-UO analyzes pharyngeal and upper-airway ultrasonic images to visualize and quantify airway structures for physician evaluation and monitoring.
Quantib BV
Quantib ND is software for the labeled brain MRI image-analysis workflow, providing release-specific visualization, measurements, or decision-support outputs for professional...
Elucid Bioimaging Inc.
vascuCAP analyzes contrast multidetector CT of arterial vessels to support atherosclerosis stratification with color maps, three-dimensional views, multiplanar reformats, and...
AMRA Medical AB
AMRA Profiler is MR diagnostic software for non-invasive fat and muscle evaluation, including liver fat fraction, T2 star, and muscle volume measurements from supported DICOM MR...
icometrix NV
icobrain segments and quantifies brain structures and lesions from MRI or noncontrast CT using cross-sectional and longitudinal workflows with acquisition-consistency limits.
NinePoint Medical, Inc.
The NvisionVLE Imaging System is an imaging tool for evaluating human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional,...
Ziosoft, Inc.
Ziostation2 is customer-hardware image-processing software for viewing, quantifying, manipulating, communicating, printing, and managing many radiological image types, with...
AIQ Solutions, Inc.
QTxI manages and evaluates supported DICOM CT and PET studies, including registration, fusion, region-of-interest contouring, quantitative analysis, and evaluation of quantitative...
Philips Medical Systems Technologies, Ltd.
Illumeo is an image-management system for trained professionals, including radiologists. It is a software package used with general-purpose computing hardware to acquire, store,...
HOLOGIC, INC.
Quantra 2.2 analyzes digital breast X-ray images and categorizes breast density to provide additional information for a radiologist's assessment.
Verathon Incorporated
BladderScan Prime PLUS is a diagnostic ultrasound system with a bladder indication for noninvasive measurement of urine volume in the bladder using the supported probe and device...
CorTechs Labs, Inc
is a fully automat ed MR imaging post -processing medical device software that provides automatic labeling, visualization and volumetric quantification of brain structures and...
Quantitative Insights, Inc
QuantX is breast MRI software for the labeled management, analysis, visualization, and decision-support workflow; exact image inputs, outputs, and use remain submission-specific.
BODY VISION MEDICAL LTD.
LungVision segments prior 3D CT and registers and overlays it with live fluoroscopic X-ray of the same anatomy to support catheter and device navigation during pulmonary...
Quantib BV
Quantib Brain is post-processing analysis software for the GE Advantage Workstation (AW 4.7) and AW Server (AWS 3.2) platforms using Volume Viewer Apps. 12.3 Ext 8 (or higher).
ARTERYS INC.
The device is intended to visualize and quantify MRI data in DICOM format.
ZEPMED, LLC.
CT CoPilotTM is intended for automatic labeling, visualization and volumetric quantification of segmentable structures from sets of CT images of the brain.
Icometrix
icobrain segments and quantifies brain structures and lesions from T1-weighted and FLAIR MRI using cross-sectional and longitudinal workflows with acquisition-consistency limits.
DIACARDIO, LTD.
LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular...
QUANTIB BV
Quantib Brain is post-processing analysis software for the GE Advantage (AW 4.7) or AW Server (AWS
HOLOGIC, INC.
Quantra version 2.1 calculates volumetric and area breast-density measures and density categories from supported digital mammography images as an adjunct, not a diagnostic result.
CIRCLE CARDIOVASCULAR IMAGING INC
cvi42 analyzes cardiovascular CT and MRI with MPR, MIP, volume rendering, centerlines, lumen and stenosis measurements, and reporting for qualified professionals.
GE MEDICAL SYSTEMS SCS
Hepatic VCAR analyzes CT liver images to assess liver morphology and liver lesions with automated liver, lobe, segment, lesion, and measurement tools that a clinician can edit and...
HOLOGIC, INC.
Quantra version 1.1 calculates a volumetric breast-density ratio from supported Hologic full-field digital mammography images on the Cenova server as an adjunct, not a diagnostic...