Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000256071

FEI Number

3000256071

Entity Name

ION BEAM APPLICATIONS S.A.

City/State/Country

LOUVAIN-LA-NEUVE, BE Brabant Wallon, BE

Establishment Address

3 CHEMIN DU CYCLOTRON, LOUVAIN-LA-NEUVE, BE Brabant Wallon 1348, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ION BEAM APPLICATIONS S.A. (Owner Number: 9034929)

Owner / Operator Contact Address

3 CHEMIN DU CYCLOTRON, --, LOUVAIN-LA-NEUVE, BE, BE-NOTA 1348, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K163500

PMA Number

N/A

All Registered Proprietary Names

Proteus Plus Proton Therapy System - Proteus 235 Proteus One

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	2017-12-14

Official Correspondent

Ronald Wichern

US Agent Details

Todd Bejian Business: IBA Proton Therapy Inc. Email: todd.bejian@iba-group.com Phone: (703) 2346561

Related Public Records

Same Entity

ION BEAM APPLICATIONS S.A.

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-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
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 3000256071. Last updated year: 2026. Please use registration number 3000256071 when referencing this establishment in official correspondence.