Directory
Search 1230 FDA-cleared radiology AI listings. Product pages distinguish exact FDA identity from buyer fields that still need verification.
Try a broader vendor, modality, anatomy, or use-case search.
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...
Philips Ultrasound, LLC
Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...
Therapixel
Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
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.
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...
Informai
RadOncAI provides AI-guided dose prediction from CT simulation and clinician-defined treatment-planning structures for adult head-and-neck malignant or benign disease.
ROPCA ApS
Supervised automatic ultrasound image acquisition of hand and wrist joints in adults being investigated or monitored for musculoskeletal disease.
GuideAI Health
VAOT is radiological computer-aided triage and notification software indicated for use in the analysis of CTA studies of adult patients. The device is intended to assist hospital...
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,...
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia, Select, Origin, and Origin ICE diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, pediatric, neonatal, cephalic, small-part,...
Crescom Co., Ltd.
MediAI-OA is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the...
Siemens Healthineers AG
LungMaps processes one or more 2D lung MRI time series to support radiologist interpretation of ventilation and perfusion maps; it is not the sole source for diagnosis.
DeepHealth, Inc.
Concurrent detection and characterization support for screening DBT mammography
Anumana, Inc.
WatchMate Software v1.2.0 processes transesophageal echocardiography data to reconstruct the left atrial appendage and assist preprocedural planning and device sizing during...
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...
Alpha Intelligence Manifolds, Inc.
DeepXray Spina is a software application intended for use opportunistically with standard frontal radiographs of the lumbar spine or KUB (kidney, ureter, and bladder) performed in...
Keya Medical Technology Co., Ltd.
Coronary plaque and stenosis quantification from CCTA
Sonio
Concurrent physician reading aid for specified abnormal fetal ultrasound findings; patient management must not rely solely on the analysis.
Deski
Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require...
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,...
OrthoGrid Systems, Inc.
OrthoGrid Hip AI 4.0 analyzes two-dimensional C-arm fluoroscopic images to assist positioning of hip-replacement components during direct-anterior total hip arthroplasty.
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...
Fujifilm Corporation
The Synapse Lung Nodule AI is a computer-assisted detection software device intended to be used as concurrent reader to aid the radiologist in the detection of pulmonary nodules...
Philips Ultrasound, LLC
EPIQ diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric,...
Philips Ultrasound, LLC
EPIQ and Affiniti ultrasound systems acquire and display the labeled diagnostic ultrasound and fluid-flow information across fetal, abdominal, cardiac, cephalic, obstetric,...
Shanghai United Imaging Healthcare Co., Ltd.
uMR Astra is a diagnostic MR system for cross-sectional and spectroscopic imaging of the labeled head, body, and extremities.
Canon Medical Informatics, Inc.
Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning is a non-invasive post-processing application designed to assist medical professionals with the assessment of the...
Wuhan United Imaging Healthcare Co.,Ltd
uSONIQUE Nova, Vita, and Grace series diagnostic ultrasound systems acquire and display the labeled whole-body, abdominal, renal, gynecologic, obstetric, pediatric, cranial,...
DeepHealth, Inc.
BAC processes screening FFDM and DBT mammograms to detect the presence or absence of breast arterial calcifications at study and breast level and localize detected calcifications...
Smart Alfa Teknoloji San. Ve Tic. A.S.
MSK Go is indicated to assist healthcare professionals trained and qualified in MSK (musculoskeletal) ultrasound by highlighting anatomical structures on musculoskeletal...
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...
Neurophet., Inc.
Brain MRI/PET registration, segmentation and quantitative PET assessment
Wuhan United Imaging Healthcare Co.,Ltd
uSONIQUE Genesis, Pulse, and Venus variants are diagnostic ultrasound systems for the labeled whole-body, fetal, obstetric, abdominal, pediatric, cranial, cardiac, vascular,...
Subtle Medical, Inc.
SubtleHD-CT is an AI/ML software intended for the processing and enhancement of CT images regardless of the manufacturer or model of CT scanner.
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...
Subtle Medical, Inc.
SubtleHD-PET 1.x is image-processing software that reduces PET or PET/CT/PET-MR image noise for images acquired with any radiotracer within the labeled workflow.
Aidoc Medical, Ltd.
BriefCase-Triage 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...
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...
AZmed
Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.
Velmeni, Inc.
VELMENI for DENTISTS (V4D) Endo-Perio is a concurrent-read, computer-assisted detection software intended to assist dentist in the clinical detection of tooth anatomy (enamel,...
Philips Ultrasound, LLC
Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling
Neurocareai, Inc. (Dba Savelife.Ai)
Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.
Canon, Inc.
Canon Intelligent NR is a noise-reduction function for fluoroscopic images acquired on compatible Canon radiography and fluoroscopy systems.
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...
Quantib B.V.
DeepHealth ProstateAI is a Computer-Aided Detection and Diagnosis (CADe/x) software device developed to aid trained physicians in the detection and characterization of prostate...
Siemens Medical Solutions USA, Inc.
Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.