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510(k) K253103

Nexus DRF Digital X-ray Imaging System by Varex Imaging Corporation — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2026
Date Received
September 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

Other clearances by Varex Imaging Corporation

  • K193238 — Nexus DR Digital X-Ray Imaging System (with vSharp) (December 20, 2019)
  • K190146 — Nexus DR Digital X-ray Imaging System (March 8, 2019)
  • K183212 — Nexus DR Digital X-ray Imaging System with stitching (December 7, 2018)
  • K181526 — XRpad2 4343 HWC-M Flat Panel Detector (July 3, 2018)
  • K172951 — Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3) (October 24, 2017)
  • K171138 — Nexus DR Digital X-ray Imaging System (May 17, 2017)

Other clearances for product code JAA

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  • K242488 — Soteria E-View (January 6, 2025)
  • K242948 — Adora DRFi (04550010) (December 23, 2024)
  • K233380 — TRIDENT Mobile Fluoroscopy System (June 26, 2024)
  • K233945 — ProxiDiagnost N90 / Precision CRF (706110, 706400) (January 11, 2024)
  • K232910 — CombiDiagnost R90 (October 19, 2023)
  • K232526 — XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 (September 12, 2023)
  • K220871 — Nautilus (April 18, 2022)
  • K212890 — Nyquist.IQ (December 13, 2021)
  • K212837 — ProxiDiagnost N90 (September 21, 2021)