FDA.reportPublic FDA data

510(k) K253406

Device
S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)
Applicant
Mevion Medical Systems, Inc.
510(k) number
K253406
Product code
LHN
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-25
Date received
2025-09-30
Regulation
892.5050
Classification name
System, Radiation Therapy, Charged-Particle, Medical
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Jason Brown
Address
300 Foster St. Littleton MA US 01460 01460

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LHN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.2026-04-23
K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)Mevion Medical Systems, Inc.2025-09-12
K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.2025-06-27
K242418P-Cure Proton Therapy System (PPTS)P-Cure, Ltd.2025-05-12
K232032PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha2024-01-12
K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc.2023-10-06
K221996P-Cure Proton Beam Therapy SystemP-Cure, Ltd.2023-03-20
K220883Small Field ApplicatorHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha2022-12-15
K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc.2022-12-01
K201798myQA iONIba Dosimetry GmbH2020-07-17
K201042PROBEAT-CRHitachi , Ltd.2020-07-13
K200282Orfit Aerial CouchtopOrfit Industries NV2020-04-08
K191821Blue Phantom PTIba Dosimetry GmbH2020-01-23
K191521Radiance 330 Proton Beam Therapy SystemProtom International Holding Corporation2019-09-27
K191801PROBEAT-CRHitachi , Ltd.2019-09-13