Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016602874

FEI Number

3016602874

Entity Name

Varian Medical Systems Haan GmbH

City/State/Country

Haan North Rhine-Westphalia, DE

Establishment Address

Rheinische Strasse 2, Haan North Rhine-Westphalia 42781, 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

Expiration Date (Year)

2026

510(k) Number

K242957

PMA Number

N/A

All Registered Proprietary Names

Intraluminal Applicator Set Mould Probe MR Safe Heyman Packing Applicator Set Guided Aarhus Applicator Set Vitesse v5 CT/ MR Tandem and Ovoid Set Heyman Packing Applicator Set (GM11004580) Surface Beacon Transponders Calypso Surface Beacon Transponders IDENTIFY 3 GammaMedplus Afterloader GammaMedplus Esophagus Bougie Set - GM11008880 VariSeed (v10) Surface Applicator Set GammaMedplus 3/24 Afterloader GammaMedplus 3/24 GammaMedplus iX Series High Dose Rate (HDR) / Pulsed Dose Rate (PDR) Afterloader system GammaMedplus iX GammaMedplus iX HDR / PDR GammaMedplus 3/24 iX HDR GammaMedplus 3/24 iX TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY Beacon Care Package - Soft Tissue (17G) Calypso Prostate Beacon Transponders Calypso Soft Tissue Beacon Transponders Calypso Permanent Beacon Transponders PLASTIC NEEDLE WITH MANDARIN 2 DIAMETER LENGTH 113MM Lead Stop Button Leak Stop Channel Marker Set, 25-30 Leak Stop Channel Marker Set, 13-24 Leak Stop Channel Marker Set, 01-12 VARIAN INTERSTITIAL TITANIUM NEEDLES Identify (5) Advanced Breast Template System Titaniuim Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve Cervical Sleeves Universal Endometrial Applicator Set Intraluminal Applicator Set Shielded Applicator Set Reusable Transfer Guide Tubes Universal Sterilization Box Mould Applicator Set APPLICATORS FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER Plastic needle 2 mm diameter Kelowna GYN and Crook Prostate Templates GammaMedplus Source Guide Tubes VARIAN NASOPHARYNX APPLICATOR The Flexible Fixation Device for Gynecological Applicators 3D Interstitial Ring Applicator Set 90 degree Ring Applicator Set 60 degree Ring Applicator Set 90 degree Ring Applicator Set 45 degree Eclipse Treatment Planning System Standard Catheter Set Universal Titanium Cervix Probe Set, even lengths Universal Titanium Cervix Probe Set, odd lengths Intracavitary/Interstitial System Titanium Flexible Geometry FSD Applicator Set (GM11013400) Kelowna GYN Template Crook Prostate Template Surface Applicator Set with Leipzig-style Cone Universal Segmented Cylinder Applicator Set Universal Cervix Probe Set, even lengths Universal Stump Applicator Set Universal Cervix Probe Set, odd lengths Intraluminal Polymeric Products VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS Flexible Interstitial Implant Tube Set Aarhus Applicator Set Interstitial Needles Identify (4)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-14
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2025-01-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-06-06
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2025-11-20
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-10-24
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2025-05-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-09-02
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2015-04-09
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2023-07-26
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2013-03-31
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-06-28
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2023-09-11
KXK	Source, Brachytherapy, Radionuclide	Radiology	Class 2	892.5730	2023-09-11
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-06-28
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2013-03-31
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2013-03-31
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-06-13
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2015-12-09
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-06-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-14
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-06-13
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2025-12-17
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-06-06
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-11-08
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-09-25
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-04-11
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-11-27
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-14
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-11-03
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-14
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-06-06
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2007-12-07
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-14
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-02-02
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-11-03
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-06-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2024-05-10
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-14
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-07-15
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-04-17
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2018-05-01
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2025-05-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2025-03-05
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-09-15
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-03-10
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2016-09-14
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-11-03
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2014-06-13
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2020-02-10
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2023-03-15
JAQ	System, Applicator, Radionuclide, Remote-Controlled	Radiology	Class 2	892.5700	2017-06-15
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2025-02-10

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 3016602874. Last updated year: 2026. Please use registration number 3016602874 when referencing this establishment in official correspondence.