510(k) Report

Devices descending from K141154

3 later devices reach Oartrac System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC20171—
+1K150719OARtrac System with Skin SensorsRadiadyne, LLC20152—
+2K182395OARtrac SystemRadialdyne, LLC201905