MEVION S250-FIT Proton Therapy System S250-FIT-VIS

by Mevion Medical Systems, Inc.

Ref S250-FIT

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing GUDID	Number00864366000148 UDI-DI	Date4 May 2026Listed	StatusListed GUDID: in commercial distribution
European Union	CE/MDR EUDAMED	Number08643660001S250L2 Basic UDI-DI 00864366000148UDI-DI	Date20 Apr 2026Registered	StatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

Active
Expiring
Withdrawn
Listed
Not covered

European Union CE/MDR Active
United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name: MEVION S250-FIT Proton Therapy System
Generic Name: Proton therapy system
Model / Ref / Catalog: S250-FIT EUDAMED
S250-FIT-VIS GUDID

Primary DI / UDI-DI: 00864366000148
Basic UDI-DI: 08643660001S250L2
Direct Marketing DI: 00864366000148
510(k) Number: K253406
FDA Product Code: LHN
EMDN Code: Z11011001 Proton therapy systems
GMDN Term: Proton therapy system

Device Class: Class IIb EUDAMED
Class II GUDID
Regulation Number: 892.5050
EU market of registration: Italy
GUDID distribution status: In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

Field	EUDAMED	GUDID
Model / Reference	EUDAMED S250-FIT	GUDID S250-FIT-VIS
Device Class	EUDAMED Class IIb	GUDID Class II

From the manufacturer

Manufacturer's product page: MEVION S250 Fit Proton Therapy SystemTM

Other devices from Mevion Medical Systems, Inc.

Mevion Medical Systems S250

Class II
S250-FIT Proton Beam Radiation Therapy Device

Class II
MEVION S250i Proton Beam Radiation Therapy Device Open recall

Class II
S-250 Proton Beam Radiation Therapy System Open recall

Class II
S250-FIT Proton Beam Radiation Therapy Device

Class II

Properties

Measuring Function
Prescription Use
Serial Number
Manufacturing Date

Other properties (20)

Sterile: No
Single Use: No
Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
CMR Substance: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Endocrine Disruptor: No
Administering Medicine: No
Incorporates Medicinal Product: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Lot / Batch Number: No
Expiration Date: No