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510(k) K193238

Nexus DR Digital X-Ray Imaging System (with vSharp) by Varex Imaging Corporation — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2019
Date Received
November 25, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Varex Imaging Corporation

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  • 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)

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