Cleared Traditional

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)

K250986 · Mevion Medical Systems, Inc. · Radiology

Sep 2025

Decision

165d

Days

Class 2

Risk

About This 510(k) Submission

K250986 is an FDA 510(k) clearance for the S250-FIT Proton Beam Radiation Therapy Device (S250-FIT), a System, Radiation Therapy, Charged-particle, Medical (Class II — Special Controls, product code LHN), submitted by Mevion Medical Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on September 12, 2025, 165 days after receiving the submission on March 31, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K250986 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 31, 2025
Decision Date	September 12, 2025
Days to Decision	165 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF