Directory
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Search 1230 FDA-cleared radiology AI listings. Product pages distinguish exact FDA identity from buyer fields that still need verification.
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Agada Medical, Ltd.
Authorized purpose: 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 surgeons.
source reviewed overview
Adas3D Medical S.L.
Authorized purpose: 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 ischemic or non-ischemic heart disease. Qualified professionals may use it for cardiac calculation, quantification, visualization, pre-planning, and electrophysiology procedures; produced data support clinical decision-making and must not be used as irrefutable medical advice or for radiotherapy planning, dose calculation, or treatment delivery.
source reviewed overview
Philips Ultrasound, LLC
Authorized purpose: Alturion Series diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric, musculoskeletal, ophthalmic, urologic, vascular, small-organ, and lung examinations.
source reviewed overview
Therapixel
Authorized purpose: Flags calcifications, masses, asymmetries and architectural distortions on compatible FFDM or DBT screening examinations; management must not be based solely on MammoScreen output.
source reviewed overview
Siemens Medical Solutions USA, Inc.
Authorized purpose: 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 coronary-lesion evaluation, documentation, follow-up and treatment planning.
source reviewed overview
Ge Medical Systems, LLC
Authorized purpose: Enhanced Boundary for PCCT is a deep-learning CT processing function for improved soft-tissue delineation in routine head examinations with or without contrast.
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Cercare Medical A/S
Authorized purpose: Cercare Neurosuite with Capillary Function and Oncology Virtual Expert processes CT or MR information to provide perfusion, tissue-blood-volume, diffusion, labeling, and quantification support for adult brain glioma workflows.
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Informai
An AI-guided planning tool that predicts radiation dose information for adult head-and-neck treatment planning.
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ROPCA ApS
Authorized purpose: Supervised automatic ultrasound image acquisition of hand and wrist joints in adults being investigated or monitored for musculoskeletal disease.
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GuideAI Health
Authorized purpose: Passive workflow prioritization for studies with imaging patterns consistent with possible total arterial occlusion in the specified vessels; not primary diagnosis, screening, disease detection, or patient-management decision support
source reviewed overview
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, and volume rendering to aid reading, interpretation, reporting, and treatment planning.
Field-derived fact summary
Siemens Medical Solutions USA, Inc.
Authorized purpose: ACUSON Sequoia, Select, Origin, and Origin ICE diagnostic ultrasound systems acquire and display the labeled fetal, abdominal, pediatric, neonatal, cephalic, small-part, obstetric, cardiac, transesophageal, intracardiac, vascular, and musculoskeletal examinations.
source reviewed overview
Crescom Co., Ltd.
Authorized purpose: Assist trained professionals in assessing radiographic knee osteoarthritis and its sclerosis, joint-space-narrowing, and osteophyte features on standing fixed-flexion knee radiographs.
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Siemens Healthineers AG
Authorized purpose: 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.
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DeepHealth, Inc.
Authorized purpose: Concurrent detection and characterization support for screening DBT mammography
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Anumana, Inc.
Authorized purpose: WatchMate Software v1.2.0 processes transesophageal echocardiography data to reconstruct the left atrial appendage and assist preprocedural planning and device sizing during left-atrial-appendage closure.
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Brainomix Limited
Authorized purpose: Provides volumetric hyperdensity segmentation and quantification as an aid; physicians must review original images.
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Mighty Oak Medical
Authorized purpose: Acorn 3D Software and Acorn 3DP Model process CT, synthetic CT, and CT angiography for segmentation, visualization, measurement, treatment planning, and three-dimensional printing, including adult and pediatric spine trajectory planning.
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Alpha Intelligence Manifolds, Inc.
Authorized purpose: Opportunistic review of frontal lumbar-spine or KUB radiographs in adults aged 50 years and older to flag possible low bone mineral density at L1-L4 for clinician follow-up; a negative result does not rule out low BMD.
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Keya Medical Technology Co., Ltd.
Authorized purpose: Coronary plaque and stenosis quantification from CCTA
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Sonio
Authorized purpose: Concurrent physician reading aid for specified abnormal fetal ultrasound findings; patient management must not rely solely on the analysis.
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Deski
Authorized purpose: Guides medical professionals acquiring ten standard 2D transthoracic echocardiographic views in adults requiring a cardiac ultrasound examination; acquired images require qualified clinical interpretation.
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HistoSonics, Inc.
Authorized purpose: 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, and patient position.
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OrthoGrid Systems, Inc.
Authorized purpose: 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.
source reviewed overview
Imeka Solutions, Inc.
Authorized purpose: ANDI 2.2 processes brain MR images for atlas-assisted visualization, segmentation and volumetric quantification, presenting adjunctive DICOM-readable information for trained medical professionals; it does not predict, diagnose or interpret brain health.
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Fujifilm Corporation
Authorized purpose: Concurrent-reader aid for a radiologist detecting pulmonary nodules during review of chest CT examinations in the lung cancer screening population under screening protocols.
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Philips Ultrasound, LLC
Authorized purpose: EPIQ diagnostic ultrasound systems acquire and display ultrasound images and fluid-flow information for the labeled fetal, abdominal, cardiac, cephalic, obstetric, musculoskeletal, vascular, small-organ, and urologic examinations.
source reviewed overview
Philips Ultrasound, LLC
Authorized purpose: EPIQ and Affiniti ultrasound systems acquire and display the labeled diagnostic ultrasound and fluid-flow information across fetal, abdominal, cardiac, cephalic, obstetric, musculoskeletal, vascular, small-organ, and urologic examinations.
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Shanghai United Imaging Healthcare Co., Ltd.
Authorized purpose: uMR Astra is a diagnostic MR system for cross-sectional and spectroscopic imaging of the labeled head, body, and extremities.
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Canon Medical Informatics, Inc.
Authorized purpose: Assist assessment and pre-operative planning and post-operative evaluation of transcatheter aortic valve replacement procedures.
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Wuhan United Imaging Healthcare Co.,Ltd
Authorized purpose: uSONIQUE Nova, Vita, and Grace series diagnostic ultrasound systems acquire and display the labeled whole-body, abdominal, renal, gynecologic, obstetric, pediatric, cranial, cardiac, vascular, musculoskeletal, and urologic examinations.
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DeepHealth, Inc.
Authorized purpose: 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 for qualified interpreting-physician review.
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Smart Alfa Teknoloji San. Ve Tic. A.S.
Authorized purpose: Assist qualified MSK-ultrasound professionals by highlighting supported joint anatomy and detection completeness on compatible adult ultrasound images; it is not a diagnostic device.
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Canon Medical Systems Corporation
Authorized purpose: 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 labeled reconstruction functions.
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Neurophet., Inc.
Authorized purpose: Brain MRI/PET registration, segmentation and quantitative PET assessment
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Wuhan United Imaging Healthcare Co.,Ltd
Authorized purpose: uSONIQUE Genesis, Pulse, and Venus variants are diagnostic ultrasound systems for the labeled whole-body, fetal, obstetric, abdominal, pediatric, cranial, cardiac, vascular, musculoskeletal, and urologic examinations.
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Subtle Medical, Inc.
Authorized purpose: Process and enhance CT images from any CT scanner manufacturer or model as an adjunct to the original reconstructed image.
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Neurophet., Inc.
Authorized purpose: Neurophet AQUA is intended for automatic labeling, visualization, and volumetric quantification of segmentable brain structures and lesions from a set of MR images; volumetric data may be compared to reference percentile data.
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Medicrea International S.A.S. (Medtronic)
Authorized purpose: UNiD Spine Analyzer SW3002 v5.1.0 enables healthcare professionals to view and measure images and plan orthopedic spine surgeries, including preoperative and postoperative measurements and patient-specific rod or implant planning.
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Subtle Medical, Inc.
PET image-processing software that reduces image noise while preserving the original images for clinical review.
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Aidoc Medical, Ltd.
Authorized purpose: Adult head CTA or mCTA triage for suspected complete large-vessel and medium-vessel occlusion.
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BeauBrain Healthcare, Inc.
Authorized purpose: Morph automatically labels, visualizes, and volumetrically quantifies segmentable brain structures from MR images and may compare measurements with reference percentile data; it is adjunctive and not the sole basis for final decisions.
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AZmed
Authorized purpose: Rayvolve supports clinicians by identifying suspected fractures, joint effusions, and dislocations on labeled radiographic views; it does not replace clinician interpretation.
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Velmeni, Inc.
Authorized purpose: Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth in patients 15 years or older.
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Philips Ultrasound, LLC
Authorized purpose: Diagnostic ultrasound; assisted abdominal FAST acquisition and anatomical labeling
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Neurocareai, Inc. (Dba Savelife.Ai)
Authorized purpose: Tags screening cases as suspicious or blank to aid worklist prioritization; radiologists must review every examination and it does not mark original images.
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Canon, Inc.
Authorized purpose: Canon Intelligent NR is a noise-reduction function for fluoroscopic images acquired on compatible Canon radiography and fluoroscopy systems.
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Fujifilm Corporation
Authorized purpose: Fujifilm Synapse 3D Base Tools V7.2 provides trained professionals with two-dimensional, three-dimensional, multiplanar, and related viewing, measurement, and analysis functions for the supported DICOM studies.
source reviewed overview
Quantib B.V.
Authorized purpose: Concurrent-reading aid for trained physicians detecting and characterizing prostate-cancer lesions in adult males aged 40 years and older undergoing prostate MRI.
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Siemens Medical Solutions USA, Inc.
Authorized purpose: Medical-image viewing and post-processing for diagnosis, interventional treatment planning and treatment control.
source reviewed overview