510(k) K254115 ยท SHW Pathology Software Algorithm Device Analyzing Digital Images For Breast Cancer Prognosis
ArteraAI Breast
| Applicant | Artera, Inc., Los Altos CA, US |
| Decision | Substantially Equivalent, May 4, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254115
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.