FDA.reportPublic FDA data

MEVION MEDICAL SYSTEMS, INC.

Matched from indexed company URL: Mevion Medical Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070870273007087027MEVION MEDICAL SYSTEMS, INC.1N2026-01-01300 Foster St Littleton MA US 01460

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1427981934272198K253406S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN2026-03-25
1427981240974730K250986S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)LHN2025-09-12
1427981770665992K172848MEVION S250i Proton Beam Radiation Therapy DeviceLHN2017-12-27
1427981339955743K120676S-250 PROTON BEAM RADIATION THERAPY SYSTEMLHN2012-06-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LHN42026-03-25

PMN#

GUDID#

MEVION S250-FIT Proton Therapy System - The MEVION S250-FIT is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation. When the patient is in the fully seated position, the MEVION S250-FIT is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the sites above the mid-chest or carina.This configuration includes an optional subsystem for 2D image verification using oblique x-rays to verify patient alignment prior to beam delivery.

MEVION MEDICAL SYSTEMS, INC.

2026-05-04

MEVION S250-FIT Proton Therapy System - he MEVION S250-FIT Proton Beam Radiation Therapy Device is intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation. When the patient is in the fully seated position, the MEVION S250-FIT is indicated for treatment of patients with localized tumors and other conditions susceptible to treatment by radiation in the sites above the mid-chest or carina.

MEVION MEDICAL SYSTEMS, INC.

2026-04-30