FDA 510(k) Application Details - K231690

Device Classification Name	More FDA Info for this Device
510(K) Number	K231690
Device Name	iCAS-LV
Applicant	HighRAD Ltd. 132 Menachem Begin Rd. Azrieli Center, Round Tower Fl.22 Tel Aviv 6702101 IL Other 510(k) Applications for this Company
Contact	Yossi Srour 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	06/09/2023
Decision Date	03/01/2024
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