FDA 510(k) Application Details - K213319

Device Classification Name	More FDA Info for this Device
510(K) Number	K213319
Device Name	Viz ANEURYSM, Viz ANX
Applicant	Viz.ai, Inc. 201 Mission St, 12th Floor San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Gregory Ramina 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	10/04/2021
Decision Date	02/18/2022
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