ArteraAI Prostate is an AI-enabled medical device from Artera Inc., listed by FDA (De Novo, DEN240068) with a decision date of 2025-07-31. Review panel: Pathology.
| FDA submission number | DEN240068 |
|---|---|
| Pathway | De Novo |
| Company | Artera Inc. |
| Review panel (specialty) | Pathology |
| FDA decision date | 2025-07-31 |
| Decision | Unknown |
| Product code | SFH |
| Classification | Pathology Software Algorithm Device Analyzing Digital Images For Prostate Cancer Prognosis |
| Device class | 2 |
| Regulation number | 864.3755 |
| Review time (calendar days) | 248 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.