510(k) K260087 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Mar 24, 2026 |
| Received | Jan 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2026 | GE Medical Systems, LLC Senographe Pristina Open, Classified |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.