FDA 510(k) Application Details - K241112

Device Classification Name	More FDA Info for this Device
510(K) Number	K241112
Device Name	BriefCase-Quantification
Applicant	Aidoc Medical, Ltd. 3 Aminadav St. Tel Aviv 6706703 IL Other 510(k) Applications for this Company
Contact	Amalia Schreier 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	04/22/2024
Decision Date	05/15/2024
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