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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K171138
Device Name Nexus DR Digital X-ray Imaging System
Applicant
Varex Imaging Corporation
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact Catherine Mulcahy
Correspondent
Varex Imaging Corporation
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact Catherine Mulcahy
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/18/2017
Decision Date 05/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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