MEVION MEDICAL SYSTEMS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3007087027	3007087027	MEVION MEDICAL SYSTEMS, INC.	1	N	2026-01-01	300 Foster St Littleton MA US 01460

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
142798	1934272198	K253406	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)	LHN	2026-03-25
142798	1240974730	K250986	S250-FIT Proton Beam Radiation Therapy Device (S250-FIT)	LHN	2025-09-12
142798	1770665992	K172848	MEVION S250i Proton Beam Radiation Therapy Device	LHN	2017-12-27
142798	1339955743	K120676	S-250 PROTON BEAM RADIATION THERAPY SYSTEM	LHN	2012-06-04

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LHN	4	2026-03-25

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
Mevion Medical Systems - Proton Beam Radiation Therapy System
MEVION MEDICAL SYSTEMS, INC.
2016-05-06
MEVION S250i - S250i
MEVION MEDICAL SYSTEMS, INC.
2018-02-05