510(k) K190442 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Koios DS for Breast
| Applicant | Koios Medical, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jul 3, 2019 |
| Received | Feb 25, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190442
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.