# K161157: Vitrea CT Dual Energy Image View

- Pathway: 510(k) (Traditional)
- Applicant: Vital Images, Inc.
- Decided: Nov 3, 2016 after 192 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: 9 generations back to K954678 (1996). 55 ancestors in all.
No later device cites it as a predicate yet.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132813: Dual Energy System Package, Toshibamedical Systems Corporation (2014) Summary page 4.

## Indications for use
The CT Dual Energy Image View application accepts CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The material composition of body regions may be determined using the energy dependence of the attenuation coefficients of different materials. This approach enables images to be generated at multiple energies within the available spectrum to visualize and analyze information about anatomical and pathological structures.

Source page: https://510kreport.com/device/K161157
Methodology: https://510kreport.com/methodology