Dual Energy System Package

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

510(k) Number

K132813 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Toshiba Medical Systems →

• What is the Dual Energy System Package used for?

  The Dual Energy System Package is a software suite for Toshiba CT systems that acquires two CT images of identical anatomy using different tube voltages/currents across two rotations. It processes raw data to measure CT values and ratios for enhanced diagnostic capabilities in radiology settings.

• How is the Dual Energy System Package supplied?

  The device is supplied by Toshiba Medical Systems Corporation as a software suite for their CT systems. It is not specified as single-use or reusable in the provided information.

• What is the regulatory status of the Dual Energy System Package?

  The Dual Energy System Package received FDA 510(k) clearance on February 6, 2014, after a 150-day review cycle. It is classified as a System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

• What are the specifications of the Dual Energy System Package?

  The device is a software package that processes raw data from Toshiba CT systems to acquire dual-energy images. It is intended for use in radiology settings and is not specified as single-use or reusable. The device was determined to be substantially equivalent through the traditional 510(k) clearance process.