510(k) K230085 ยท MYN Analyzer, Medical Image
Lung-CAD
| Applicant | Imagen Technologies, Inc., New York NY, US |
| Decision | Substantially Equivalent, Oct 3, 2023 |
| Received | Jan 11, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230085
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.