FDA 510(k) Application Details - K230074

Device Classification Name	More FDA Info for this Device
510(K) Number	K230074
Device Name	Rapid Aneurysm Triage and Notification
Applicant	iSchemaView Inc. 1120 Washington Ave., Ste 200 Golden, CO 80401 US Other 510(k) Applications for this Company
Contact	James Rosa Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QFM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2023
Decision Date	07/27/2023
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