510(k) Report

Devices descending from K210747

2 later devices reach Caption Interpretation Automated Ejection Fraction Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+1K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—