# K180225: GSI Viewer with GSI Fat Option

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Apr 24, 2018 after 88 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: 7 generations back to K013561 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121827: Gsi Viewer with Vue Option, GE Medical Systems SCS (2012) Summary page 4.

## Indications for use
The GSI Viewer accepts images from a CT System that can acquire CT images using different kV levels of the same anatomical region of a patient in a single rotation from a single source. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. This approach enables images to be generated at energies selected from the available spectrum to visualize and analyze information about anatomical and pathological structures. GSI provides information of the chemical composition of renal calculi by calculation and graphical display of the spectrum of effective atomic number. GSI Kidney stone characterization provides additional information to aid in the characterization of uric acid versus non-uric acid stones. It is intended to be used on non-contrast studies as an adjunct to current standard methods for evaluating stone etiology and composition.

Source page: https://510kreport.com/device/K180225
Methodology: https://510kreport.com/methodology