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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 K181003
Device Name VIVIX-S 1717V
Applicant
Vieworks Co., Ltd.
(Gwanyang-dong) 41-3, Burim-ro 170beon-gil,
Dongan-gu
Anyang-si,  KR 431-060
Applicant Contact Jordin Kim
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number892.1680
Classification Product Code
MQB  
Date Received04/16/2018
Decision Date 05/15/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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