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NZT — Dosimeter, Ionizing Radiation, Implanted Class II

FDA Device Classification

Classification Details

Product Code
NZT
Device Class
Class II
Regulation Number
892.5050
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
Yes

Definition

Verify radiation dose to organs from external radiation therapy.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250083nu-risePRO-DOSE SystemOctober 1, 2025
K182395radialdyneOARtrac SystemMarch 22, 2019
K162954radiadyneOARtrac System with Patient Specific Reusable Universal PSD SensorsJune 1, 2017
K150719radiadyneOARtrac System with Skin SensorsJune 16, 2015
K141154radiadyneOARTRAC SYSTEMJuly 22, 2014
K083035sicel technologiesDOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMNovember 13, 2008
K080004sicel technologiesDOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEMJanuary 23, 2008