Nexus DR Digital X-ray Imaging System With Stitching

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 Stitching.

Pre-market Notification Details

Device IDK183212
510k NumberK183212
Device Name:Nexus DR Digital X-ray Imaging System With Stitching
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 Received2018-11-19
Decision Date2018-12-07
Summary:summary

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