510(k) K190809 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Sample Imaging for Senographe Pristina
| Applicant | GE Healthcare, Buc, FR |
| Decision | Substantially Equivalent, Jul 29, 2019 |
| Received | Mar 29, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190809
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.