Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1717855

FEI Number

1717855

Entity Name

Varex Imaging Corporation

City/State/Country

SALT LAKE CITY, UT, US

Establishment Address

1678 South Pioneer Road, SALT LAKE CITY, UT 84104, US

Establishment Type(s)

Manufacture Medical Device

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

K193238

PMA Number

N/A

All Registered Proprietary Names

XRPad2 3025 HWC-M Interay Varex Imaging Corporation Nexus DRF Digital X-ray Imaging System XRPad2 4343 HWC-M XRPad2 4336 HWC-M Nexus DR Digital X-Ray Imaging System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-06-08
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2016-12-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2016-12-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2016-12-15
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2019-02-12
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2017-06-08
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2021-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
3006383214	Varex Imaging Nederland B.V.	Doetinchem Gelderland, NL
3009519933	Varex Imaging Philippines Inc.	Batino, Calamba City Laguna, PH
3010601176	MEVIS MEDICAL SOLUTIONS AG	Bremen, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16
K190691	Pixxgen Corporation	Pixx2430 Digital Diagnostic X-Ray Receptor Panel	2019-04-04
K150150	Rayence Co., Ltd.	1717SGN / 1717SCN Digital Flat Panel X-ray Detector	2015-03-27
K140771	Philips Medical Systems Dmc GmbH	PHILIPS ELEVA WORKSPOT	2014-04-25
K863853	Superior Medical Products	EAZY COVERS	1987-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2009	Toshiba American Medical Systems Inc	2	Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007	AGFA Corp.	2	CR DX-S, Image Intensified Fluoroscopic X-ray system.
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1717855. Last updated year: 2026. Please use registration number 1717855 when referencing this establishment in official correspondence.