510(k) K934373 ยท IZH System, X-Ray, Mammographic
MOBILE SOPHIE MODIFICATION
| Applicant | Planmed OY, Helsinki, FI |
| Decision | Substantially Equivalent, Apr 7, 1994 |
| Received | Sep 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934373
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.