Data / Medical devices / United States / Varex Imaging Corporation
Varex Imaging Corporation: FDA-registered device maker in Salt Lake City, UT, United States, 5 510(k) clearances
Varex Imaging Corporation is registered with the FDA (registration 1717855) in Salt Lake City, UT, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 20, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1717855
- Address
- 1678 South Pioneer Road, Salt Lake City, UT, United States, 84104
- Owner or operator
- Varex Imaging Corporation (10053550)
- Roles
- Manufacturer
- First device listed
- December 15, 2016
- Registered through
- 2026
- Brand names listed
- Interay, Nexus DR Digital X-Ray Imaging System, Nexus DRF Digital X-ray Imaging System, Varex Imaging Corporation, XRPad2 3025 HWC-M, XRPad2 4336 HWC-M, XRPad2 4343 HWC-M
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 20, 2019 | K193238 | Nexus DR Digital X-Ray Imaging System (with vSharp) | MQB | Substantially Equivalent | Varex Imaging Corporation | accessdata.fda.gov |
| July 3, 2018 | K181526 | XRpad2 4343 HWC-M Flat Panel Detector | MQB | Substantially Equivalent | Varex Imaging Corporation | accessdata.fda.gov |
| September 8, 2016 | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | MQB | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| September 1, 2016 | K161942 | PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector | MQB | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| April 22, 2013 | K130318 | NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB) | JAA | Substantially Equivalent | Varian Medical Systems, X-Ray Products-Infimed | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Assembly, Tube Housing, X-Ray, Diagnostic
Updated December 20, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.