510(k) K250221 ยท POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
StrokeSENS ASPECTS Software Application
| Applicant | Circle Cardiovascular Imaging, Inc., Calgary, CA |
| Decision | Substantially Equivalent, Jul 1, 2025 |
| Received | Jan 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250221
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.