Allix5 is an AI-enabled medical device from Clairity, Inc., listed by FDA (De Novo, DEN240047) with a decision date of 2025-05-30. Review panel: Radiology.
| FDA submission number | DEN240047 |
|---|---|
| Pathway | De Novo |
| Company | Clairity, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-05-30 |
| Decision | Unknown |
| Product code | SEZ |
| Classification | Radiological Software Device To Predict Future Breast Cancer Risk |
| Device class | 2 |
| Regulation number | 892.8500 |
| Review time (calendar days) | 266 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.