# K132902: Syngo Dual Energy Software Package

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 7, 2014 after 203 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). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062351: Syngo Dual Energy, Siemens Medical Solutions USA, Inc. (2006) Summary page 2.
- K083524: Syngo Dual Energy with Extended Funationally, Siemens Medical Solutions USA, Inc. (2009) Summary page 2.

## Indications for use
syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. 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® Dual Energy applications are as follows: * Lung Nodules — Dual Energy Bone Removal * Monoenergetic — Cartilage, Tendon, Ligament * Brain Haemorrhage — Lung Perfusion * Gout Evaluation — Liver * Lung Vessels — Hard Plaques in Vessels * Heart PBV — Kidney Stones Kidney Stones is designed to support the visualization of the chemical composition of kidney stones and especially the differentiation between uric acid and non-uric acid stones. For full identification of the kidney stone additional clinical information should be considered such as patient history and urine testing. Only a well-trained radiologist can make the final diagnosis under consideration of all available information. The accuracy of identification is decreased in obese patients.

Source page: https://510kreport.com/device/K132902
Methodology: https://510kreport.com/methodology