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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, Stationary
510(k) Number K160620
Device Name Visaris Vision® (Vision C, Vision U. Vision V, Vision X)
Applicant
Visaris D.O.O. Belgrade
Batajnicki Drum 10 Deo 1b
Zemun,  RS 11080
Applicant Contact MILAN RATKOVIC
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1680
Classification Product Code
KPR  
Date Received03/04/2016
Decision Date 03/30/2016
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
Recalls CDRH Recalls
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