MEVION MEDICAL SYSTEMS, INC.

FDA Device Registration & Listing · Littleton, MA, US · Registration 3007087027

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007087027
FEI Number
3007087027
Entity Name
MEVION MEDICAL SYSTEMS, INC.
City/State/Country
Littleton, MA, US
Establishment Address
300 Foster St, Littleton, MA 01460, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Mevion Medical Systems, Inc. (Owner Number: 10041144)
Owner / Operator Contact Address
300 Foster Street, Littleton, MA 01460, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K253406
PMA Number
N/A

All Registered Proprietary Names

Mevion S250-FIT Proton Therapy System / S250-FIT / FIT FIT PROTON THERAPY IN YOUR LINAC VAULT S250-FIT Proton Beam Radiation Therapy Device

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2025-12-12
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2026-04-29

Official Correspondent

Ping Hu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mevion Medical Systems, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2009 Intraop Medical Corporation 2
Mobetron Model 1000, mobile electron linear accelerator, a device system which delivers radiation to an intraoperative site.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007087027. Last updated year: 2026. Please use registration number 3007087027 when referencing this establishment in official correspondence.
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