Advanced Therapy Dosimeter

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K942083 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Tn-Rd-50

  Class II

  FDA 510(k) K932598 Active Cleared 3 Jun 1994

• Model 35300 Tracker Therapy Beam Evaluator

  Class II

  FDA 510(k) K874893 Active Cleared 17 Feb 1988

• Keithley Model 75100 & 75200

  Class II

  FDA 510(k) K854110 Active Cleared 6 Mar 1986

• What is the Advanced Therapy Dosimeter primarily used for in a clinical setting?

  The Advanced Therapy Dosimeter is designed to measure charge and current from ion chambers in radiation therapy, ensuring precise dose measurements during treatment. It provides accurate bias voltage calibration for clinical ion chambers, which is essential for verifying the accuracy of radiation delivered in radiology departments.

• Is the Advanced Therapy Dosimeter intended for single-use or reusable applications?

  The device is explicitly supplied as a reusable instrument, meaning it is not designed for single-use. It is intended to be used repeatedly in clinical settings, provided it is properly maintained and calibrated.

• How does the Advanced Therapy Dosimeter account for environmental factors during dose measurements?

  The device includes front-panel controls for adjusting temperature and pressure inputs, allowing users to correct for air density variations. This ensures accurate dose measurements by accounting for environmental conditions that could otherwise affect calibration.

• What type of regulatory clearance does the Advanced Therapy Dosimeter hold, and how does it relate to its use?

  The device holds FDA 510(k) clearance (K942083) as substantially equivalent to a predicate device, adhering to Class II medical device standards under 21 CFR 892.5050. This clearance confirms its compliance with regulatory requirements for use in radiation therapy calibration, ensuring safety and performance in clinical settings.

• Does the Advanced Therapy Dosimeter require any special handling or storage conditions?

  While the device is reusable and non-sterile, it must be stored in a clean, controlled environment to prevent contamination or damage. Since it is not sterile, it should not be exposed to conditions that could compromise its accuracy or functionality, such as extreme temperatures or humidity.