Device Tracker
FDA-Cleared AI Devices in Radiology
Imaging triage, detection, quantification, and reconstruction. The largest category of authorized medical AI by a wide margin.
| Device | Manufacturer | Route | Year | Modality | Function |
|---|---|---|---|---|---|
| Aidoc BriefCase | Aidoc | 510(k) | 2018 onward | CT | Flags suspected findings for prioritized review |
| AIR Recon DL | GE HealthCare | 510(k) | 2020 | MRI | Deep learning MRI reconstruction from raw data |
| Annalise Enterprise CTB | Annalise.ai | 510(k) | 2021 onward | CT | Multi-finding triage on non-contrast brain CT |
| Arterys Cardio AI | Arterys | 510(k) | 2017 | Cardiac MRI | Automated ventricular contouring and quantification |
| Critical Care Suite | GE HealthCare | 510(k) | 2019 | Chest X-ray | On-device pneumothorax detection at the point of acquisition |
| HealthPNX | Nanox AI | 510(k) | 2019 | Chest X-ray | Flags suspected pneumothorax on chest radiographs |
| Lunit INSIGHT CXR | Lunit | 510(k) | 2021 onward | Chest X-ray | Multi-finding detection on chest radiographs |
| Lunit INSIGHT MMG | Lunit | 510(k) | 2021 onward | Mammography | Detection and abnormality scoring for mammography |
| Optellum Virtual Nodule Clinic | Optellum | 510(k) | 2021 | CT | Assigns malignancy risk scores to lung nodules |
| OsteoDetect | Imagen Technologies | De Novo | 2018 | X-ray | Detects distal radius fractures on wrist radiographs |
| ProFound AI | iCAD | 510(k) | 2018 | Digital breast tomosynthesis | Detects and scores suspicious findings in tomosynthesis |
| Rapid ICH | RapidAI | 510(k) | 2019 onward | CT | Flags suspected intracranial hemorrhage on non-contrast head CT |
| SubtleMR | Subtle Medical | 510(k) | 2019 | MRI | Denoising and resolution enhancement on acquired MRI |
| SubtlePET | Subtle Medical | 510(k) | 2018 | PET | Denoising for reduced-dose or shortened PET acquisitions |
| Transpara | ScreenPoint Medical | 510(k) | 2018 onward | Mammography and tomosynthesis | Region-level and exam-level scoring for breast screening |
| TrueFidelity CT | GE HealthCare | 510(k) | 2019 | CT | Deep learning CT image reconstruction |
| Viz LVO | Viz.ai | De Novo | 2018 | CT angiography | Detects suspected large vessel occlusion and alerts the stroke team |