FDA 510(k) Application Details - K210670

Device Classification Name	More FDA Info for this Device
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 10663 TW Other 510(k) Applications for this Company
Contact	Hsin Hung Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2021
Decision Date	12/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review