FDA 510(k) Application Details - K241543

Device Classification Name	More FDA Info for this Device
510(K) Number	K241543
Device Name	DrAidÖ for Liver Segmentation
Applicant	VinBrain Joint Stock Company No 7 Bang Lang 1 Street, Vinhomes Riverside Ecological Urban Area, Long Bien District, Hanoi Hanoi 100000 VN Other 510(k) Applications for this Company
Contact	Steven Quoc Hung Truong 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	05/31/2024
Decision Date	12/06/2024
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