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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 K163703
Device Name VIVIX-S 1417N
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.
800 ROOSEVELT STE 417
IRVINE,  CA  92620
Correspondent Contact PRISCILLA CHUNG
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/29/2016
Decision Date 02/08/2017
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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