510(k) Report

Devices descending from K200621

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K210747Caption Interpretation Automated Ejection Fraction SoftwareCaption Health20222—
+2K253593Clarius Ejection Fraction AIClarius Mobile Health Corp.20260—
+2K232331InVision Precision LVEF (LVEF)InVision Medical Technology Corporation20240—