# K083524: Syngo Dual Energy with Extended Funationally

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Apr 1, 2009 after 124 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 K954678 (1996). 47 ancestors in all.
117 later devices descend from it; 7 cite it directly.
1 of 165 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073003: Syngo Dual Energy with Extended Functionally, Siemens Medi Cal Solutions, Inc. (2008) Summary page 2.
- K071310: Syngo CT Oncology Software Package, Siemens AG (2007) Summary page 2.
- K837107: Somatom Dri X-Ray CT Scanner, Siemens Medical Solutions USA, Inc. (1983) Summary page 2.

## Most influential descendants
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K150843: syngo®.via (version VB10A) (2015), 46 descendants of its own
- K163294: syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology (2017), 23 descendants of its own
- K180336: syngo.MR Applications (2018), 21 descendants of its own

## 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 * Xenon (Lung Ventilation) * Monoenergetic * Brain Haemorrhage * Gout Evaluation * Lung Vessels * Heart PBV * Dual Energy Bone Removal * Cartilage, Tendon, Ligament * Lung Perfusion * Liver * Hard Plaques in Vessels * Kidney Stones

Source page: https://510kreport.com/device/K083524
Methodology: https://510kreport.com/methodology