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510(k) K253406

S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) by Mevion Medical Systems, Inc. — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2026
Date Received
September 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Mevion Medical Systems, Inc.

  • K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (September 12, 2025)
  • K172848 — MEVION S250i Proton Beam Radiation Therapy Device (December 27, 2017)
  • K120676 — S-250 PROTON BEAM RADIATION THERAPY SYSTEM (June 4, 2012)

Other clearances for product code LHN

  • K250986 — S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) (September 12, 2025)
  • K243900 — eMotus Respiratory Motion Management System (June 27, 2025)
  • K242418 — P-Cure Proton Therapy System (PPTS) (May 12, 2025)
  • K232032 — PROBEAT-FR (January 12, 2024)
  • K231863 — ProBeam 360° Proton Therapy System v2.0 (Multiroom) (October 6, 2023)
  • K221996 — P-Cure Proton Beam Therapy System (March 20, 2023)
  • K220883 — Small Field Applicator (December 15, 2022)
  • K221791 — ProBeam 360° Proton Therapy System (December 1, 2022)
  • K201798 — myQA iON (July 17, 2020)
  • K201042 — PROBEAT-CR (July 13, 2020)