510(k) K213998 ยท QIH Automated Radiological Image Processing Software
cvi42 Auto Imaging Software Application
| Applicant | Circle Cardiovascular Imaging, Inc., Calgary, CA |
| Decision | Substantially Equivalent, Jul 28, 2022 |
| Received | Dec 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213998
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.