510(k) Report

Devices descending from K083035

4 later devices reach Dose Verification System Patient Dosimetry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141154Oartrac SystemRadiadyne20143—
+2K162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC20171—
+2K150719OARtrac System with Skin SensorsRadiadyne, LLC20152—
+3K182395OARtrac SystemRadialdyne, LLC201905