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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Diagnostic Radiology
510(k) Number K161057
Device Name Diagnostic Imaging Color LCD Monitor
Applicant
Nec Display Solutions , Ltd.
4-28, Mita 1-Chome, Minato-Ku
Tokyo,  JP
Applicant Contact SATORU KOTANI
Correspondent
Top Victory Electronics (Taiwan) Co., Ltd.
10f, # 230, Liancheng Rd. Zhonghe Dist.
New Taipei City,  TW 23559
Correspondent Contact DAVID CHENG
Regulation Number892.2050
Classification Product Code
PGY  
Date Received04/14/2016
Decision Date 05/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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