MOSFET Autosense, Model TN-RD-60

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

510(k) Number

K013279 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Mosfet Autosense Wireless

  Class II

  FDA 510(k) K032725 Active Cleared 3 Oct 2003

• Patient Dose Verification System, Model Tn-Rd-50

  Class II

  FDA 510(k) K010472 Active Cleared 8 May 2001

• Mobilemosfet Wireless Dosimetry System, Model Tn-Rd-70-W

  Class II

  FDA 510(k) K041557 Active Cleared 25 Jun 2004

• What is the MOSFET Autosense, Model TN-RD-60, used for in clinical settings?

  The MOSFET Autosense, Model TN-RD-60, is a Patient Dose Verification System designed specifically for linear medical accelerators in radiology. It uses MOSFET technology to monitor and verify the accuracy of radiation dose delivery during therapy sessions, ensuring consistent and precise treatment parameters.

• Is the MOSFET Autosense, Model TN-RD-60, a single-use or reusable device?

  The MOSFET Autosense, Model TN-RD-60, is supplied as a reusable system. Proper calibration and maintenance are required to ensure reliable performance over repeated use.

• What regulatory pathway was followed for the FDA clearance of this device?

  The MOSFET Autosense, Model TN-RD-60, received FDA clearance through a 510(k) submission (K013279) with a Substantially Equivalent (SESE) determination. This classification reflects compliance with regulatory standards for linear accelerator dose verification, and the device is classified as a Class II medical device under 21 CFR 892.5050.

• How is the MOSFET Autosense, Model TN-RD-60, intended to be integrated into existing radiology workflows?

  The MOSFET Autosense, Model TN-RD-60, is intended for use with linear medical accelerators in radiology settings. It functions as a verification tool to ensure accurate radiation dose delivery during therapy, helping to maintain treatment consistency and reliability within established workflows.

• What type of maintenance does the MOSFET Autosense, Model TN-RD-60, require to remain effective?

  Since the MOSFET Autosense, Model TN-RD-60, is a reusable system, it requires regular calibration and maintenance to ensure its accuracy and reliability. Proper upkeep is essential for consistent performance in verifying radiation dose delivery during therapy sessions.