FDA 510(k) Application Details - K251766

Device Classification Name	More FDA Info for this Device
510(K) Number	K251766
Device Name	TumorSight Viz
Applicant	SimBioSys, Inc. 320 N Sangamon Street Suite 700 Chicago, IL 60607 US Other 510(k) Applications for this Company
Contact	Kimberly Oleson 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	06/09/2025
Decision Date	07/08/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review