FDA 510(k) Application Details - K241098

Device Classification Name	More FDA Info for this Device
510(K) Number	K241098
Device Name	NeuroQuant
Applicant	CorTechs Labs, Inc. 5060 Shoreham Place CA Ste 240 San Diego, CA 92122 US Other 510(k) Applications for this Company
Contact	Kora Marinkovic 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	04/22/2024
Decision Date	08/22/2024
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