510(k) K904953 ยท IZH System, X-Ray, Mammographic
PLANMED SOPHIE
| Applicant | Planmeca USA, Inc., Finland, FI |
| Decision | Substantially Equivalent, Apr 18, 1991 |
| Received | Nov 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904953
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.