Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003793371

FEI Number

3003793371

Entity Name

Varian Medical Systems Finland 0y

City/State/Country

Helsinki Uusimaa, FI

Establishment Address

Alvar Aallon katu 5C, Helsinki Uusimaa FI-00100, FI

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

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

K232923

PMA Number

N/A

All Registered Proprietary Names

Eclipse Treatment Planning System v18.1 Ethos Treatment Management v 2.1 Ethos Treatment Planning v 1.1 Eclipse Treatment Planning System Halcyon Ethos Radiotherapy System Eclipse Treatment Planning System Eclipse Treatment Planning System v 15.6 Eclipse Treatment Planning System v16 Ethos Treatment Management 3, Ethos Treatment Planning 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-12-12
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
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-07-15
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-02-11
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2020-02-11
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	2018-05-22
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-04-07
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2024-05-01
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-05-01

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
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05
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-0014-2012	Elekta, Inc.	2	Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Z-0038-2017	RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden	2	RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003793371. Last updated year: 2026. Please use registration number 3003793371 when referencing this establishment in official correspondence.