510(k) K242781 ยท QIH Automated Radiological Image Processing Software
cvi42 Software Application
| Applicant | Circle Cardiovascular Imaging, Inc., Calgary, CA |
| Decision | Substantially Equivalent, Oct 15, 2024 |
| Received | Sep 16, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242781
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.