S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)— 510(k) K253406
Substantially EquivalentMevion Medical Systems, Inc.
FDA 510(k) clearance K253406 for S250-FIT Proton Beam Radiation Therapy Device (S250-FIT), Substantially Equivalent on 2026-03-25. Applicant: Mevion Medical Systems, Inc.. Device class: 2.
Summary
Mevion Medical Systems' S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) is filed under LHN, medical charged-particle radiation therapy systems. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).
Mevion Medical Systems filed from Littleton, Massachusetts. The decision came 176 calendar days after receipt (September 30, 2025 to March 25, 2026).
Clearance details
- Applicant
- Mevion Medical Systems, Inc.
- Product code
- Product code LHN
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Littleton, MA, US
Recent devices under product code LHN
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