FDA-Cleared AI Devices in Radiology
A curated directory of 17 FDA-authorized radiology AI records across triage, detection, scoring, quantification, and image reconstruction.
This directory contains 17 radiology AI device records with manufacturer, regulatory route, year, modality, and clinical function. It is a curated working set, not the complete FDA inventory.
The records show why a single label such as radiology AI is too broad. Some products flag a suspected time-critical finding, some mark or score an abnormality, and others reconstruct or denoise an image without making a diagnostic claim.
| 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 |
What The 17 Radiology AI Records Cover
Triage and notification: products such as Aidoc BriefCase, Rapid ICH, and Viz LVO flag a suspected finding or alert a care team so a study can be reviewed sooner. The output changes workflow priority. It does not replace the radiologist's interpretation.
Detection and scoring: the directory includes chest X-ray, mammography, tomosynthesis, wrist radiograph, and CT products that mark, score, or characterize a finding. Their intended uses differ, so a shared modality does not make the clinical claims interchangeable.
Image reconstruction and enhancement: AIR Recon DL, SubtleMR, SubtlePET, and TrueFidelity CT operate on image quality or reconstruction. These tools can support acquisition or reading quality without detecting a disease.
How To Read The Regulatory Column
Most records use 510(k), which means the manufacturer demonstrated substantial equivalence to a legally marketed predicate for the stated intended use. De Novo establishes a new device type for a novel low-to-moderate-risk device without a suitable predicate. In either case, the authorization applies to the stated device and intended use. It does not establish superiority over a radiologist or over every alternative workflow.
Why The Official FDA List Still Matters
The FDA says its AI-enabled medical device list is updated periodically and is not comprehensive. Use the linked FDA database entry and current labeling to verify a product before relying on any directory record. This page organizes current examples for comparison; it does not replace the FDA record.
For the workflow view, read how radiology AI is used in practice. For the task definitions behind the functions column, use the AI diagnostics guide.