OARtrac System with Skin Sensors

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K150719 ↗

FDA Product Code

NZT

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Prostate Immobilizer Rectal Balloon

  Class II

  FDA De Novo DEN130036 Active Cleared 28 Jan 2014 FDA 510(k)

• Alatus Vaginal Balloon Packing System

  Class II

  FDA 510(k) K092534 Active Cleared 7 Dec 2009

• OARtrac System with Patient Specific Reusable Universal PSD Sensors

  Class II

  FDA 510(k) K162954 Active Cleared 1 Jun 2017

• Oartrac System

  Class II

  FDA 510(k) K141154 Active Cleared 22 Jul 2014

• What clinical purpose does the OARtrac System with Skin Sensors serve?

  It is a dosimeter designed to monitor ionizing radiation dose at multiple points on the patient’s skin in near real‑time, helping clinicians verify that the prescribed radiation dose is being delivered accurately during cancer therapy.

• How is the device applied and what additional components are needed?

  The sensor is adhered to the patient’s skin using a medical‑grade adhesive, and a medical‑grade bolus buildup is placed directly over the sensor. These components together ensure proper coupling of the radiation field to the sensor for accurate dose measurement.

• Is the OARtrac System supplied ready for use or does it require calibration?

  The system is supplied as a pre‑calibrated device, meaning the manufacturer has performed the necessary calibration before shipment, so the user does not need to perform additional calibration steps before clinical use.

• Can the OARtrac System be reused or is it a single‑use product?

  The provided data do not specify sterility, single‑use, or reusable status, so the intended reuse classification is unclear. Users should consult the manufacturer’s labeling or instructions for guidance on reuse or disposal.

• What regulatory clearance does the OARtrac System have?

  The device received FDA 510(k) clearance (K150719) as a Class II dosimeter (product code NZT), indicating it is substantially equivalent to a legally marketed predicate device.