Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003094912

FEI Number

3003094912

Entity Name

Varian Medical Systems Imaging Laboratory GmbH

City/State/Country

Daettwil, Argovia Aargau, CH

Establishment Address

Taefernstrasse 7, Daettwil, Argovia Aargau CH-5405, CH

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

Expiration Date (Year)

2026

510(k) Number

K212294

PMA Number

N/A

All Registered Proprietary Names

Respiratory Gating for Scanners Mobius Verification Phantom Varian SRS E2E Phantom DoseLab Phantom Set ARIA Radiation Therapy Management (v18) Respiratory Gating for Scanners (2.1) PortalVision Advanced Imaging ARIA Radiation Therapy Management System v18.1 ARIA Radiation Therapy Management (v16.1 MR3) Eclipse Treatment Planning System (v18) DoseLab Pro Eclipse Treatment Planning System v18.1 FractionLab DoseLab TG-142 MaximQA Eclipse Treatment Planning System Respiratory Gating for Scanners (RGSC) Gating Reflector Block Eclipse Treatment Planning System v16 Eclipse Treatment Planning System Ethos Treatment Management v 2.1 Ethos Treatment Planning v 1.1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-01-18
IXG	Phantom, Anthropomorphic, Radiographic	Radiology	Class 1	892.1950	2018-03-09
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-04-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-06-05
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-03-31
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-12-16
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2022-06-17
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2023-05-30
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-03-09
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-12-12
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2000-04-26
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-07-15
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2016-03-03
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-11-22
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-04-07
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2016-03-03
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2021-08-20
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-08-20

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

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003094912. Last updated year: 2026. Please use registration number 3003094912 when referencing this establishment in official correspondence.