510(k) K192317 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Planmed Clarity 2D and Clarity S
| Applicant | Planmed OY, Helsinki, FI |
| Decision | Substantially Equivalent, Oct 23, 2020 |
| Received | Aug 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192317
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.