FDA 510(k) Application Details - K210209

Device Classification Name	More FDA Info for this Device
510(K) Number	K210209
Device Name	Viz ICH
Applicant	Viz.ai, Inc. 350 Rhode Island St, Suite 240 San Francisco, CA 94103 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	QAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/2021
Decision Date	03/23/2021
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