FDA 510(k) Application Details - K231398

Device Classification Name	More FDA Info for this Device
510(K) Number	K231398
Device Name	VUNO Med-DeepBrain
Applicant	VUNO Inc. 9F, 479, Gangnam-daero, Seocho-gu Seoul 06541 KR Other 510(k) Applications for this Company
Contact	Jiwon Song 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	05/15/2023
Decision Date	10/04/2023
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