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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., #410, Sec.5m Zhongxiao E. Rd., Xinyi Dist.
Taipei,  TW
Applicant Contact HSIN HUNG(SIMON) LAI
Correspondent
Lin & Associates, LLC
9223 Cambridge Manor Ct.
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
Predetermined Change
Control Plan Authorized		 No
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