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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 K152894
Device Name VIVIX-S 1717N
Vieworks Co., Ltd
(Gwanyang-dong) 41-3, Burim-ro 170beon-gil,
Anyang-si,  KR 431-060
Applicant Contact Yoonjae Im
LK Consulting Group USA, Inc.
2651 E Chapman Ave Ste 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number892.1680
Classification Product Code
Date Received09/30/2015
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