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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 K161459
Device Name Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4)
Applicant
Varian Medical Systems, X-Ray Products-Infimed
121 Metropolitan Dr.
Liverpool,  NY  13088
Applicant Contact Catherine Mulcahy
Correspondent
Varian Medical Systems, X-Ray Products-Infimed
121 Metropolitan Dr.
Liverpool,  NY  13088
Correspondent Contact Catherine Mulcahy
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/26/2016
Decision Date 09/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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