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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
510(k) Number K210670
Device Name BU-CAD
Applicant
TaiHao Medical Inc.
6F.-1, No.100, Sec. 2 Heping E. Rd., Da'an Dist.
Taipei,  TW 10663
Applicant Contact Hsin Hung
Correspondent
TaiHao Medical Inc.
6F.-1, No.100, Sec. 2 Heping E. Rd., Da'an Dist.
Taipei,  TW 10663
Correspondent Contact Hsin Hung
Classification Product Code
QDQ  
Subsequent Product Code
LLZ  
Date Received03/05/2021
Decision Date 12/21/2021
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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