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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
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