FDA 510(k) Application Details - K243189

Device Classification Name	More FDA Info for this Device
510(K) Number	K243189
Device Name	TumorSight Viz
Applicant	SimBioSys, Inc. 320 N Sangamon, 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	09/30/2024
Decision Date	10/25/2024
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