510(k) K232156 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
Rapid ASPECTS (v3)
| Applicant | Ischemaview, Inc., Golden CO, US |
| Decision | Substantially Equivalent, Jan 19, 2024 |
| Received | Jul 20, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232156
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.