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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 K152855
Device Name VIVIX-S 1012N
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.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact PRISCILLA CHUNG
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/29/2015
Decision Date 02/26/2016
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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