FDA 510(k) Application Details - K250670

Device Classification Name	More FDA Info for this Device
510(K) Number	K250670
Device Name	EchoConfidence (USA)
Applicant	Mycardium AI Limited The Spine 2 Paddington Village Liverpool L7 3FA GB Other 510(k) Applications for this Company
Contact	Michael Walker 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	03/05/2025
Decision Date	06/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review