FDA 510(k) Application Details - K233108

Device Classification Name	More FDA Info for this Device
510(K) Number	K233108
Device Name	VinDr-Mammo
Applicant	VinBigData Joint Stock Company Symphony Office Building, Chu Huy Man Street, Vinhomes Riverside Ecological Urban Area Ha Noi 100000 VN Other 510(k) Applications for this Company
Contact	Nguyet (Jun) Phan 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	09/27/2023
Decision Date	05/23/2024
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