510(k) K983659 ยท IZH System, X-Ray, Mammographic
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC
| Applicant | Planmed OY, Helsinki, FI |
| Decision | Substantially Equivalent, Nov 16, 1998 |
| Received | Oct 19, 1998 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K983659
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.