Varian Medical Systems Particle Therapy GmbH & Co. KG

FDA Device Registration & Listing · Troisdorf North Rhine-Westphalia, DE · Registration 3010658895

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
3010658895
FEI Number
3010658895
Entity Name
Varian Medical Systems Particle Therapy GmbH & Co. KG
City/State/Country
Troisdorf North Rhine-Westphalia, DE
Establishment Address
Landgrafenstrasse 106-114, Troisdorf North Rhine-Westphalia D-53842, DE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Varian Medical Systems, Inc (Owner Number: 2914292)
Owner / Operator Contact Address
3100 Hansen Way, --, Palo Alto, CA 94304, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221791
PMA Number
N/A

All Registered Proprietary Names

ProBeam 360° Proton Therapy System v3 ProBeam Proton Therapy System ProBeam 360° Proton Therapy System v2 (Multiroom) ProBeam 360° Proton Therapy System

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 2026-04-27
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2014-08-01
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2023-10-19
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2022-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

Ali Rezaei Business: Varian Medical Systems, Inc. Email: Ali.Rezaei@varian.com Phone: (650) 4246545

Related Public Records

Same Entity

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

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007157255 Varian Medical Systems, Inc. Atlanta, GA, US
3007791541 Varian Medical Systems China Co., Ltd. Beijing, CN
3009754495 Varian Medical Systems International India Private Ltd Pune Maharashtra, IN
3025765259 Varian Medical Systems Haan GmbH Manufacturing site Kemnath Kemnath Bavaria, DE
3022977243 Varian Medical Systems, Inc. Shoreview, MN, US

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 3010658895. Last updated year: 2026. Please use registration number 3010658895 when referencing this establishment in official correspondence.
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