FDA 510(k) Application Details - K220439

Device Classification Name	More FDA Info for this Device
510(K) Number	K220439
Device Name	Viz SDH
Applicant	Viz.ai, Inc. 201 Mission St, 12th Floor San Francisco, CA 94105 US Other 510(k) Applications for this Company
Contact	Vi Ma 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	02/16/2022
Decision Date	07/25/2022
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