# K150719: OARtrac System with Skin Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Radiadyne, LLC
- Decided: Jun 16, 2015 after 89 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: 9 generations back to K011332 (2001). 16 ancestors in all.
2 later devices descend 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)
- K141154: Oartrac System, Radiadyne (2014) Summary page 4.

## Most influential descendants
- K162954: OARtrac System with Patient Specific Reusable Universal PSD Sensors (2017), 1 descendant of its own
- K182395: OARtrac System (2019), 0 descendants of its own

## Indications for use
The OARtrac® System pre-calibrated skin sensors are specifically indicated for use during cancer treatments to measure photon beam therapy as an adjunct to treatment planning permitting measurement of radiation dose received on the surface of the skin. OARtrac® System pre-calibrated skin sensors are indicated for use when adhered to the surface of the skin using medical grade adhesive and with a medical grade bolus buildup placed directly on top of the sensor.

Source page: https://510kreport.com/device/K150719
Methodology: https://510kreport.com/methodology