Dosimeter, Ionizing Radiation, Implanted
Radiology · 21 CFR 892.5050
Verify radiation dose to organs from external radiation therapy.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
5 recall events for this product code
- Angiodynamics, Inc.TerminatedUnknown
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL
May result in readings outside of the expected accuracy range.
Z-0709-2020 · View FDA record ↗ - Angiodynamics, Inc.TerminatedUnknown
OARtrac PLUS CLINICAL DETECTOR UNIT
May result in readings outside of the expected accuracy range.
Z-0710-2020 · View FDA record ↗ - Angiodynamics, Inc.TerminatedUnknown
MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and ele
May result in readings outside of the expected accuracy range.
Z-0711-2020 · View FDA record ↗ - Angiodynamics, Inc.TerminatedUnknown
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron
May result in readings outside of the expected accuracy range.
Z-0712-2020 · View FDA record ↗ - Angiodynamics, Inc.TerminatedUnknown
MICRO-PSD EXTERNAL BEAM PHOTON, Catalog Number: PSD-PE5N - Product Usage: pre-calibrated PSD sensors are intended for use during cancer treatments to measure ph
May result in readings outside of the expected accuracy range.
Z-0713-2020 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
7 clearances for this product code
- Nu-Rise, SAOct 1, 2025
K250083 · PRO-DOSE System
- Radialdyne, LLCMar 22, 2019
K182395 · OARtrac System
- Radiadyne, LLCJun 1, 2017
K162954 · OARtrac System with Patient Specific Reusable Universal PSD Sensors
- Radiadyne, LLCJun 16, 2015
K150719 · OARtrac System with Skin Sensors
- RadiadyneJul 22, 2014
K141154 · OARTRAC SYSTEM
- Sicel Technologies, Inc.Nov 13, 2008
K083035 · DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
- Sicel Technologies, Inc.Jan 23, 2008
K080004 · DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM