510(k) K962105 ยท IZH System, X-Ray, Mammographic
PLANNED SOPHIED CLASSIC
| Applicant | Planmed OY, Helsinki, FI |
| Decision | Substantially Equivalent, Feb 5, 1997 |
| Received | May 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962105
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.