510(k) K251027 ยท QIH Automated Radiological Image Processing Software
cvi42 Coronary Plaque Software Application
| Applicant | Circle Cardiovascular Imaging, Inc., Calgary, CA |
| Decision | Substantially Equivalent, Oct 27, 2025 |
| Received | Apr 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251027
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.