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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 K171709
Device Name BR-FHUS Viewer 1.0
Applicant
TaiHao Medical Inc.
3F.-8, No.100, Sec. 2
Heping E. Rd., Da'an Dist.
Taipei,  TW 10663
Applicant Contact Hsin Hung (Simon) Lai
Correspondent
Lin & Associates, LLC
5614 Johnson Avenue
Bethesda,  MD  20817
Correspondent Contact Chiu S. Lin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/08/2017
Decision Date 10/20/2017
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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