510(k) K202212 ยท LLZ System, Image Processing, Radiological
TruPlan
| Applicant | Circle Cardiovascular Imaging, Inc., Calgary, CA |
| Decision | Substantially Equivalent, Feb 19, 2021 |
| Received | Aug 6, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202212
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.