# K182395: OARtrac System

- Pathway: 510(k) (Traditional)
- Applicant: Radialdyne, LLC
- Decided: Mar 22, 2019 after 199 days
- Product code: NZT (Dosimeter, Ionizing Radiation, Implanted)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K011332 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors, Radiadyne, LLC (2017) Summary page 4.

## Recalls of this device
- Nov 19, 2019 · Class II · Z-0709-2020: May result in readings outside of the expected accuracy range.
- Nov 19, 2019 · Class II · Z-0712-2020: May result in readings outside of the expected accuracy range.
- Nov 19, 2019 · Class II · Z-0710-2020: May result in readings outside of the expected accuracy range.
- Nov 19, 2019 · Class II · Z-0711-2020: May result in readings outside of the expected accuracy range.
- Nov 19, 2019 · Class II · Z-0713-2020: May result in readings outside of the expected accuracy range.

## Indications for use
The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.

Source page: https://510kreport.com/device/K182395
Methodology: https://510kreport.com/methodology