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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 Ste 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
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