510(k) K232661 ยท LLZ System, Image Processing, Radiological
Myocardial Strain Software Application
| Applicant | Circle Cardiovascular Imaging, Calgary, CA |
| Decision | Substantially Equivalent, Dec 7, 2023 |
| Received | Aug 31, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232661
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.