# K122909: Syngo Single Source Dual Engery

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Systems, Inc.
- Decided: Dec 27, 2012 after 97 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). 62 ancestors in all.
13 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083524: Syngo Dual Energy with Extended Funationally, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.
- K073373: Syngo Volume Perfusion-CT Body, Siemens AG Medical Solutions (2007) Summary page 2.

## Most influential descendants
- K133677: Syngo CT Single Source Dual Energy (2014), 12 descendants of its own
- K150745: syngo.CT Single Source Dual Energy (2015), 11 descendants of its own
- K173625: syngo.CT Clinical Extensions (2018), 5 descendants of its own
- K192402: syngo.CT Extended Functionality (2019), 4 descendants of its own
- K191468: syngo.CT Dual Energy (2019), 4 descendants of its own

## Indications for use
syngo® Single Source Dual Energy is designed to operate with CT images taken at the same anatomical region of a patient using two different kV levels. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Single Source Dual Energy applications are as follows: * Gout Evaluation * Monoenergetic

Source page: https://510kreport.com/device/K122909
Methodology: https://510kreport.com/methodology