510(k) Report

FDA applicant

Varex Imaging Corporation

Liverpool, NY7 decisions2017–20260 recalls

FDA records 7 decisions for Varex Imaging Corporation (Liverpool, NY) from 2017 to 2026: 7 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and JAA (System, X-Ray, Fluoroscopic, Image-Intensified). Since 2016 its 510(k)s took a median of 27 days from receipt to decision, against 30 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Varex Imaging Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2019

2017: 22018: 22019: 22026 (partial year): 1
2017high 2 (2017) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Varex Imaging Corporation by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Varex Imaging Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)6decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 27 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 30 days; 5 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 4 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 20191cites it
  • K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 20171cites it
  • K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation · 20181cites it
  • K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation · 20171cites it

What has FDA decided for it lately?

  • K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging Corporation · 2026
  • K193238Nexus DR Digital X-Ray Imaging System (with vSharp)Varex Imaging Corporation · 2019
  • K190146Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2019
  • K183212Nexus DR Digital X-ray Imaging System with stitchingVarex Imaging Corporation · 2018
  • K181526XRpad2 4343 HWC-M Flat Panel DetectorVarex Imaging Corporation · 2018
  • K172951Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)Varex Imaging Corporation · 2017
  • K171138Nexus DR Digital X-ray Imaging SystemVarex Imaging Corporation · 2017

All 7 as Varex Imaging Corporation →