Nexus DR Digital X-Ray Imaging System (with VSharp)

Solid State X-ray Imager (flat Panel/digital Imager)

Varex Imaging Corporation

The following data is part of a premarket notification filed by Varex Imaging Corporation with the FDA for Nexus Dr Digital X-ray Imaging System (with Vsharp).

Pre-market Notification Details

Device IDK193238
510k NumberK193238
Device Name:Nexus DR Digital X-Ray Imaging System (with VSharp)
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Varex Imaging Corporation 121 Metropolitan Drive Liverpool,  NY  13088
ContactMichael Van Ryn
CorrespondentMichael Van Ryn
Varex Imaging Corporation 121 Metropolitan Drive Liverpool,  NY  13088
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2019-12-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00854344007726 K193238 000
00854344007696 K193238 000
00854344007672 K193238 000
00854344007733 K193238 000
00854344007740 K193238 000

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