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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 K190611
Device Name VIVIX-S 1751S
Applicant
Vieworks Co., Ltd.
(Gwanyang-Dong) 41-3, Burim-Ro 170beon-Gil
Anyang-Si,  KR 431-060
Applicant Contact Jordin Kim
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/11/2019
Decision Date 04/08/2019
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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