FDA 510(k) Application Details - K251342

Device Classification Name	More FDA Info for this Device
510(K) Number	K251342
Device Name	EchoPAC Software Only / EchoPAC Plug-in
Applicant	GE Medical Systems Ultrasound and Primary Care Diagnostics 3200 N Grandview Blvd Waukesha, WI 53188 US Other 510(k) Applications for this Company
Contact	Lee Bush 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	04/30/2025
Decision Date	07/16/2025
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