FDA 510(k) Application Details - K242062

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K242062
Device Name	System, Image Processing, Radiological
Applicant	Mycardium AI Limited The Spine, 2 Paddington Village Liverpool L73FA GB Other 510(k) Applications for this Company
Contact	Michael Walker 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	07/15/2024
Decision Date	11/15/2024
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