FDA 510(k) Application Details - K241350

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K241350
Device Name	System, Image Processing, Radiological
Applicant	GE Medical Systems Israel, Functional Imaging 4 Hayozma Street Tirat Hacarmel IL Other 510(k) Applications for this Company
Contact	Mousa Elias Maysana Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2024
Decision Date	01/03/2025
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