FDA 510(k) Applications for Medical Device Product Code: NZT (Dosimeter, Ionizing Radiation, Implanted)

FDA 510(k) Applications for Medical Device Product Code "NZT"
(Dosimeter, Ionizing Radiation, Implanted)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K141154	RADIADYNE	OARTRAC SYSTEM	07/22/2014
K162954	RADIADYNE, LLC	OARtrac System with Patient Specific Reusable Universal PSD Sensors	06/01/2017
K150719	RadiaDyne, LLC	OARtrac System with Skin Sensors	06/16/2015
K182395	RadialDyne, LLC	OARtrac System	03/22/2019
K080004	SICEL TECHNOLOGIES, INC.	DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM	01/23/2008
K083035	SICEL TECHNOLOGIES, INC.	DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM	11/13/2008