FDA 510(k) Application Details - K232363

Device Classification Name	More FDA Info for this Device
510(K) Number	K232363
Device Name	Viz HDS, Viz Volume Plus, Viz ICH+
Applicant	Viz.ai, Inc. 201 Mission St 12th Floor San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Pooja Shah 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	08/07/2023
Decision Date	02/05/2024
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