510(k) K951883 ยท IZH System, X-Ray, Mammographic
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT
| Applicant | Planmed OY, Helsinki, FI |
| Decision | Substantially Equivalent, May 24, 1995 |
| Received | Apr 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951883
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.