FDA 510(k) Application Details - K203555

Device Classification Name	More FDA Info for this Device
510(K) Number	K203555
Device Name	AmCAD-UT
Applicant	AmCad BioMed Corporation FL. 5-2, No.167, Fu Hsing N. RD. Taipei 105 TW Other 510(k) Applications for this Company
Contact	Nathan Liu Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/07/2020
Decision Date	09/08/2021
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