510(k) K250963 ยท MUJ System, Planning, Radiation Therapy Treatment
PlanOne 1
| Applicant | Cosylab Jsc, Control System Laboratory, Ljubljana, SI |
| Decision | Substantially Equivalent, Nov 20, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250963
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.