510(k) K131885 ยท MUE Full Field Digital, System, X-Ray, Mammographic
SENOGRAPHE ESSENTIAL, PREMIUM VIEW I (PVI)
| Applicant | GE Medical Systems SCS, Buc, FR |
| Decision | Substantially Equivalent, Sep 26, 2013 |
| Received | Jun 25, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131885
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.