FDA 510(k) Applications for Medical Device Product Code: SDJ ()

FDA 510(k) Applications for Medical Device Product Code "SDJ"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K250151	Eko.ai Pte. Ltd. d/b/a Us2.ai	Us2.ca	06/20/2025
K243866	InVision Medical Technology Corporation	InVision Precision Cardiac Amyloid	05/21/2025
K240860	Ultromics Limited	EchoGo Amyloidosis (1.0)	11/15/2024