510(k) Report

Devices descending from K080004

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083035Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc.20084—
+2K141154Oartrac SystemRadiadyne20143—
+3K162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC20171—
+3K150719OARtrac System with Skin SensorsRadiadyne, LLC20152—
+4K182395OARtrac SystemRadialdyne, LLC201905