FDA 510(k) Application Details - K240712

Device Classification Name	More FDA Info for this Device
510(K) Number	K240712
Device Name	icobrain aria
Applicant	icometrix NV Kolonel Begaultlaan 1b/12 Leuven 3012 BE Other 510(k) Applications for this Company
Contact	Dirk Smeets Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2024
Decision Date	11/07/2024
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