# K141154: Oartrac System

- Pathway: 510(k) (Traditional)
- Applicant: Radiadyne
- Decided: Jul 22, 2014 after 78 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: 8 generations back to K011332 (2001). 15 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K083035: Dose Verification System Patient Dosimetry System, Sicel Technologies, Inc. (2008) Summary page 2.
- DEN130036: Prostate Immobilizer Rectal Balloon, Radiadyne (2014). Our reading of the summary gave K132194, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130036, Prostate Immobilizer Rectal Balloon (Radiadyne), granted Jan 28, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K150719: OARtrac System with Skin Sensors (2015), 2 descendants of its own
- 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 OARtract System is specifically indicated for male prostate cancer treatment to measure photon beam therapy as an adjunct to treatment planning permitting measuremeni of in-viva radiation dose received on the anterior surface of a modified Prostate Immobilization Endorectal Balloon (ERB) device to monitor and verify the surrounding organs at risk, specifically the protatic rectal interface.

Source page: https://510kreport.com/device/K141154
Methodology: https://510kreport.com/methodology