ArteraAI Breast is an AI-enabled medical device from Artera, Inc., listed by FDA (510(k), K254115) with a decision date of 2026-05-04. Review panel: Pathology.
| FDA submission number | K254115 |
|---|---|
| Pathway | 510(k) |
| Company | Artera, Inc. |
| Review panel (specialty) | Pathology |
| FDA decision date | 2026-05-04 |
| Decision | Substantially Equivalent |
| Product code | SHW |
| Classification | Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis |
| Device class | 2 |
| Regulation number | 864.3755 |
| Review time (calendar days) | 136 |
| 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.