510(k) K250986 ยท LHN System, Radiation Therapy, Charged-Particle, Medical
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
| Applicant | Mevion Medical Systems, Inc., Littleton MA, US |
| Decision | Substantially Equivalent, Sep 12, 2025 |
| Received | Mar 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250986
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.