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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K130318
Device Name NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM (WITH PAXSCAN 4343CB)
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 Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
MQB  
Date Received02/08/2013
Decision Date 04/22/2013
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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