510(k) K254090 · MUE Full Field Digital, System, X-Ray, Mammographic
I-View®
| Applicant | Hologic, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Sep 2, 2026 |
| Received | Dec 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254090
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.