K253406
- 510(k) number
- K253406
- Device name
- S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
- Applicant
- Mevion Medical Systems, Inc. MA · US
- Product code
- LHN — System, Radiation Therapy, Charged-Particle, Medical
- Decision date
- 2026-03-25
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K253406.pdf
Official FDA record: K253406
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.