510(k) K211215 ยท MUE Full Field Digital, System, X-Ray, Mammographic
SenoBright HD
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, Jun 22, 2021 |
| Received | Apr 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211215
| 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.