Nexus DR Digital X-ray Imaging System

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.

Pre-market Notification Details

Device IDK171138
510k NumberK171138
Device Name:Nexus DR Digital X-ray Imaging System
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant Varex Imaging Corporation 121 Metropolitan Drive Liverpool,  NY  13088
ContactCatherine Mulcahy
CorrespondentCatherine Mulcahy
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 Received2017-04-18
Decision Date2017-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00854344007016 K171138 000

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