Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006894636

FEI Number

3006894636

Entity Name

Siemens Healthineers AG Varian Cancer Therapy (CTH)

City/State/Country

Erlangen Bavaria, DE

Establishment Address

Doris-Ruppenstein-Str. 4, Erlangen Bavaria 91052, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Varian Medical Systems, Inc (Owner Number: 2914292)

Owner / Operator Contact Address

3100 Hansen Way, --, Palo Alto, CA 94304, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K993425

PMA Number

N/A

All Registered Proprietary Names

syngo RT Therapist Workspace, v4.3.1 & optional 3rd party OIS Connectivity System ARTISTE; ARTISTE Solution ONCOR / PRIMUS Linac with ARIA OIS update myAblation Guide (VC10A) 550 TXT TREATMENT TABLE syngo Dosimetrist V2.7 myAblation Guide (Version VB80A) ONCOR Avant Garde; ONCOR FAMILY; PRIMUS FAMILY ONCOR Expression ONCOR 160 MLC ARTISTE Solution V4.3; ARTISTE Solution with SYS_VC10 COHERENCE RTT Connect; syngo RTT Connect syngo.via RT Image Suite VC10 syngo.CT Clinical Extensions ARTISTE Solution, Sys_VC10C Phase 2 update, with the syngo RT Therapist and RT Oncologist Workspaces, v4.3.1_MR1 KONRAD TREATMENT PLANNING SOFTWARE PRIMUS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
QTZ	Radiological Image Processing Software For Ablation Therapy Planning And Evaluation	Radiology	Class 2	892.2050	2026-06-18
JAI	Couch, Radiation Therapy, Powered	Radiology	Class 2	892.5770	2024-10-03
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-10-03
QTZ	Radiological Image Processing Software For Ablation Therapy Planning And Evaluation	Radiology	Class 2	892.2050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2026-04-14
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-10-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-10-03

Official Correspondent

Ali Rezaei

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
3025765259	Varian Medical Systems Haan GmbH Manufacturing site Kemnath	Kemnath Bavaria, DE

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
K033316	Brainlab AG	TABLE TILT DEVICE	2004-05-14
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

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

Similar Registrations

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3014113695	JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.	Wuxi Jiangsu, CN
1722661	RADIOLOGICAL IMAGING TECHNOLOGY, INC.	Co Spgs, CO, US
3030077501	CHABNER XRT, LLC	Port Chester, NY, US
3007791541	Varian Medical Systems China Co., Ltd.	Beijing, CN
1932738	MEDTEC LLC	Orange City, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006894636. Last updated year: 2026. Please use registration number 3006894636 when referencing this establishment in official correspondence.