510(k) K213353 ยท MYN Analyzer, Medical Image
Aorta-CAD
| Applicant | Imagen Technologies, Inc., New York NY, US |
| Decision | Substantially Equivalent, Sep 20, 2022 |
| Received | Oct 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213353
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.