S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)— 510(k) K253406

Name: FDA 510(k) clearance K253406
Creator: U.S. Food and Drug Administration
Published: 2026-03-25

Substantially Equivalent

Mevion 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.

Clearance details

Applicant: Mevion Medical Systems, Inc.
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2025-09-30
Decision date: 2026-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, MA, US

Download summary PDF View on FDA.gov ↗

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K260174 — PROBEAT-CR2026-06-11
K252815 — ProBeam 360 Proton Therapy System v3.02026-04-23
K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)2025-09-12
K243900 — eMotus Respiratory Motion Management System2025-06-27
K242418 — P-Cure Proton Therapy System (PPTS)2025-05-12

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