510(k) K251769 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
RevealAI-Lung
| Applicant | Precision Medical Ventures, Inc. Dba Revealdx, Seattle WA, US |
| Decision | Substantially Equivalent, Jan 30, 2026 |
| Received | Jun 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251769
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.