FDA 510(k) Application Details - K231130

Device Classification Name	More FDA Info for this Device
510(K) Number	K231130
Device Name	TumorSight Viz
Applicant	SimBioSys, Inc. 180 North Lasalle Street, Suite 3250 Chicago, IL 60601 US Other 510(k) Applications for this Company
Contact	Tricia Carrigan 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	04/20/2023
Decision Date	12/26/2023
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