Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006383214

FEI Number

3006383214

Entity Name

Varex Imaging Nederland B.V.

City/State/Country

Doetinchem Gelderland, NL

Establishment Address

Fabriekstraat 41, Doetinchem Gelderland 7005 AP, NL

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Varex Imaging Corporation (Owner Number: 10053550)

Owner / Operator Contact Address

1678 South Pioneer Road, Salt Lake City, UT 84104, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ICX Series, INX Series SolidStateMC 609 Series AmpMC 1007 Series SolidStateMC 605 Series AmpMC 1006 Series SolidStateMC 502 Series SolidStateMC 508 Series AmpMC 1001 Series SolidStateMC 621 Series AmpMC 1002 Series SolidStateMC 601 Series SolidStateMC 625 Series SolidStateMC 521 Series SolidStateMC 501 Series SolidStateMC 616 Series SolidStateMC 510 Series SolidStateMC 506 Series SolidStateMC 619 Series SolidStateMC 613 Series SolidStateMC 610 Series AmpMC 1008 Series SolidStateMC 614 Series SolidStateMC 617 Series AmpMC 1012 Series

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2018-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

Evangelina Garza Business: Varex Imaging Americas Corporation Email: qara.nl@vareximaging.com Phone: (847) 2795100

Related Public Records

Same Entity

Varex Imaging Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014205374	Varex Imaging Equipment (China) Co., LTD	Wuxi Jiangsu, CN
1483291	Varex Imaging Corporation	Franklin Park, IL, US
3009519933	Varex Imaging Philippines Inc.	Batino, Calamba City Laguna, PH
1717855	Varex Imaging Corporation	SALT LAKE CITY, UT, US
3010601176	MEVIS MEDICAL SOLUTIONS AG	Bremen, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23

Similar Registrations

Registration Number	Establishment Name	Location
1483291	Varex Imaging Corporation	Franklin Park, IL, US
3007603422	Althea US, Inc.	Goodlettsville, TN, US
3000126629	Philips Electronics Ltd	Mississauga Ontario, CA
3003768251	Philips Medical Systems DMC GmbH	HAMBURG, DE
1450503	SUMMIT INDUSTRIES, LLC	Niles, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006383214. Last updated year: 2026. Please use registration number 3006383214 when referencing this establishment in official correspondence.