# K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Radiadyne, LLC
- Decided: Jun 1, 2017 after 220 days
- Product code: NZT (Dosimeter, Ionizing Radiation, Implanted)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K011332 (2001). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150719: OARtrac System with Skin Sensors, Radiadyne, LLC (2015) Summary page 5.
- K141154: Oartrac System, Radiadyne (2014) Summary page 5.

## Most influential descendants
- K182395: OARtrac System (2019), 0 descendants of its own

## Indications for use
The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon 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, and indicated for use when adhered to the skin with a bolus, or inserted into the rectum to measure the rectal prostatic interface via a specifically designed endorectal balloon device.

Source page: https://510kreport.com/device/K162954
Methodology: https://510kreport.com/methodology