Varian Medical Systems Haan GmbH Manufacturing site Kemnath

FDA Device Registration & Listing · Kemnath Bavaria, DE · Registration 3025765259

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
3025765259
FEI Number
3025765259
Entity Name
Varian Medical Systems Haan GmbH Manufacturing site Kemnath
City/State/Country
Kemnath Bavaria, DE
Establishment Address
Building C10 Roentgenstrasse 19-21, Kemnath Bavaria 95478, 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
K222941
PMA Number
N/A

All Registered Proprietary Names

Halcyon, Ethos Radiotherapy System Halcyon, Ethos Radiotherapy System (5) Halcyon Ethos Radiotherapy System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2024-02-21
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2026-01-22
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2023-01-19

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
3010658895 Varian Medical Systems Particle Therapy GmbH & Co. KG Troisdorf North Rhine-Westphalia, DE
3009754495 Varian Medical Systems International India Private Ltd Pune Maharashtra, IN
3022977243 Varian Medical Systems, Inc. Shoreview, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

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3007791541 Varian Medical Systems China Co., Ltd. Beijing, CN
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025765259. Last updated year: 2026. Please use registration number 3025765259 when referencing this establishment in official correspondence.
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