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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K161113
Device Name QXLink
Applicant
Vieworks Co., Ltd.
(Gwanyang-Dong) 41-3, Burim-Ro 170beon-Gil
Anyang-Si,  KR 431-060
Applicant Contact YOONJAE IM
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt
Suite 417
Irvine,  CA  92620
Correspondent Contact PRISCILLA CHUNG
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/20/2016
Decision Date 08/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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