# K132813: Dual Energy System Package

- Pathway: 510(k) (Traditional)
- Applicant: Toshibamedical Systems Corporation
- Decided: Feb 6, 2014 after 150 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K954678 (1996). 54 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120833: Discovery CT750 HD, Ge Medical Systems, LLC (2012) Summary page 2.
- K083524: Syngo Dual Energy with Extended Funationally, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.

## Cited in the summary but kept off the family tree
- K006002: Brilliance Dual Energy Option. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K182601: Vitrea Software Package, VSTP-001A (2018), 0 descendants of its own
- K161157: Vitrea CT Dual Energy Image View (2016), 0 descendants of its own

## Indications for use
The Dual Energy System allows the system to acquire two CT images of the same anatomical location using distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the dose of each tube rotation at its respective tube voltage and current. Information regarding the material composition of various organs, tissues, and contrast materials may be gained from the differences in x-ray attenuation between these distinct energies. This information may also be used to reconstruct images at multiple energies within the available spectrum, and to reconstruct basis images that allow the visualization and analysis of anatomical and pathological materials. The visualization of the differentiation between uric acid and non-uric acid stones greater than 3mm and the visualization of uric acid presence within surrounding anatomical structures is provided with the Dual Energy system. When used by a qualified physician, a potential application is to determine the course of treatment. Performance of this device may be affected by body size and motion artifacts.

Source page: https://510kreport.com/device/K132813
Methodology: https://510kreport.com/methodology