Paige Prostate is an AI-enabled medical device from Paige.AI, listed by FDA (De Novo, DEN200080) with a decision date of 2021-09-21. Review panel: Pathology.
| FDA submission number | DEN200080 |
|---|---|
| Pathway | De Novo |
| Company | Paige.AI |
| Review panel (specialty) | Pathology |
| FDA decision date | 2021-09-21 |
| Decision | Unknown |
| Product code | QPN |
| Classification | Software Algorithm Device To Assist Users In Digital Pathology |
| Device class | 2 |
| Regulation number | 864.3750 |
| Review time (calendar days) | 264 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Pathology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.