FDA 510(k) Application Details - K250354

Device Classification Name	More FDA Info for this Device
510(K) Number	K250354
Device Name	Viz Subdural+, Viz SUBDURAL PLUS
Applicant	Viz.ai, Inc. 5000 Center Green Way Cary, NC 27513 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	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/07/2025
Decision Date	06/10/2025
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