510(k) K193334 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Pristina Serena Bright
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, May 15, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2024 | GE Medical Systems, SCS 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.