510(k) K253884 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Koios DS (3.8)
| Applicant | Koios Medical, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jul 2, 2026 |
| Received | Dec 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253884
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.