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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K151075
Device Name BR-ABVS Viewer 1.0
Applicant
TAIHAO MEDICAL INC.
7F., NO.410, SEC.5M ZHONGXIAO E. RD., XINYI DIST.
TAIPEI,  TW
Applicant Contact HSIN HUNG(SIMON) LAI
Correspondent
LIN & ASSOCIATES, LLC
9223 CAMBRIDGE MANOR COURT
POTOMAC,  MD  20854
Correspondent Contact CHIU S LIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/22/2015
Decision Date 01/15/2016
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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