FDA-Cleared AI Product Index
Note
Draft chapter — outline only. Content coming soon.
| modality | product | vendor | clearance | indication | link | notes |
|---|---|---|---|---|---|---|
| cxr | Critical Care Suite | GE HealthCare | 510(k) | Pneumothorax triage on mobile X-ray | https://www.gehealthcare.com/ | On-device triage |
| cxr | red dot | Behold.ai | 510(k) | Abnormality triage | https://behold.ai/ | UK-origin |
| cxr | Lunit INSIGHT CXR | Lunit | 510(k) | Multi-finding detection | https://www.lunit.io/ | Widely deployed internationally |
| ct | Viz LVO | Viz.ai | De Novo (2018) | Large-vessel-occlusion stroke triage | https://www.viz.ai/ | First CADt De Novo; created the reimbursement path |
| ct | Aidoc BriefCase (ICH/PE) | Aidoc | 510(k) | Intracranial hemorrhage & PE triage | https://www.aidoc.com/ | Platform with many cleared modules |
| ophtho | IDx-DR (LumineticsCore) | Digital Diagnostics | De Novo (2018) | Autonomous diabetic-retinopathy screening | https://www.digitaldiagnostics.com/ | First autonomous AI diagnosis clearance |
| mammo | Transpara | ScreenPoint Medical | 510(k) | Breast-cancer detection in mammography/DBT | https://screenpoint-medical.com/ | Strong reader-study evidence |
| echo | Caption Guidance | Caption Health (GE) | De Novo (2020) | AI-guided echo acquisition for novices | https://www.gehealthcare.com/ | Acquisition guidance not diagnosis |
| path | Paige Prostate | Paige.AI | De Novo (2021) | Prostate-cancer detection in WSI | https://paige.ai/ | First FDA-authorized pathology AI |
| video | GI Genius | Medtronic/Cosmo | De Novo (2021) | Real-time colonoscopy polyp detection | https://www.medtronic.com/ | First cleared endoscopy CADe |