510(k) K253406 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, Mar 25, 2026 |
| Received | Sep 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253406
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.