510(k) K250064 ยท MUJ System, Planning, Radiation Therapy Treatment
Dose+ (1.0)
| Applicant | Mvision AI OY, Helsinki, FI |
| Decision | Substantially Equivalent, Sep 4, 2025 |
| Received | Jan 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250064
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.