FDA 510(k) Application Details - K241232

Device Classification Name	More FDA Info for this Device
510(K) Number	K241232
Device Name	GalenÖ Second ReadÖ
Applicant	Ibex Medical Analytics Ltd. 101 Rokach Blvd Tel Aviv 6153101 IL Other 510(k) Applications for this Company
Contact	Yael Liebes Peer Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QPN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2024
Decision Date	01/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review