510(k) K250318 ยท SFV X-Ray, Computed Tomography, Cone-Beam
Planmed XFI
| Applicant | Planmed OY, Helsinki, FI |
| Decision | Substantially Equivalent, Sep 26, 2025 |
| Received | Feb 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250318
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.