510(k) K200760 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Rapid ASPECTS
| Applicant | Ischemaview, Inc., Golden CO, US |
| Decision | Substantially Equivalent, Jun 26, 2020 |
| Received | Mar 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200760
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.