510(k) K261519 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Sonio Suspect
| Applicant | Sonio, Paris, FR |
| Decision | Substantially Equivalent, Jun 4, 2026 |
| Received | May 7, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K261519
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.