FDA 510(k) Application Details - K221241

Device Classification Name	More FDA Info for this Device
510(K) Number	K221241
Device Name	DrAid for Radiology v1
Applicant	VinBrain Joint Stock Company No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological Urban Area Viet Hung Ward, Long Bien District VN Other 510(k) Applications for this Company
Contact	Nguyen Nhat Linh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/29/2022
Decision Date	09/01/2022
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