510(k) K202822 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Helianthus
| Applicant | Metaltronica Spa, Pomezia Rm, IT |
| Decision | Substantially Equivalent, Dec 15, 2021 |
| Received | Sep 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202822
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.