# K090462: Brilliance Dual Energy Option

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 23, 2009 after 120 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: 6 generations back to K930090 (1993). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060937: Brilliance Volume, Philips Medical Systems (Cleveland), Inc. (2006) Summary page 1.
- K081105: GE Lightspeed CT750 HD (Lightspeed 8.0), GE Healthcare (2008) Summary page 1.

## Most influential descendants
- K093703: 3DI (2010), 2 descendants of its own
- K112530: 3DI Including Cscore (2011), 1 descendant of its own
- K113442: 3DI (2012), 0 descendants of its own

## Indications for use
The Brilliance CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories. The dual energy option allows the system to acquire two CT images of the same anatomical location using two distinct tube voltages and/or tube currents during two tube rotations. The x-ray dose will be the sum of the doses 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.

Source page: https://510kreport.com/device/K090462
Methodology: https://510kreport.com/methodology