FDA 510(k) Application Details - K250416

Device Classification Name	More FDA Info for this Device
510(K) Number	K250416
Device Name	GBrain MRI
Applicant	Galileo CDS, Inc 7000 North Mopac ExpresswayáSuite 200á Austin, TX 78731 US Other 510(k) Applications for this Company
Contact	Abhijeet Pradhan 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	02/13/2025
Decision Date	04/11/2025
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