FDA 510(k) Application Details - K251009

Device Classification Name	More FDA Info for this Device
510(K) Number	K251009
Device Name	Cirrus Resting State fMRI Software
Applicant	Sora Neuroscience, Inc. 4406 Beard Ave. S. Suite UL2 Minneapolis, MN 55410 US Other 510(k) Applications for this Company
Contact	Stephen Schaefer 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	04/01/2025
Decision Date	06/06/2025
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