# K062351: Syngo Dual Energy

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 5, 2006 after 55 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: 5 generations back to K954355 (1995). 17 ancestors in all.
169 later devices descend from it; 2 cite it directly.
1 of 187 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040970: Leonardo, Siemens Medical Systems, Inc. (2004) Summary page 2.
- K043469: Syngo Inspace 4D, Siemens AG Medical Solutions (2005) Summary page 2.
- K050867: Syngo Body Perfusion-CT, Siemens AG (2005) Summary page 2.

## Cited in the summary but kept off the family tree
- K830710: Argyle Silicone Salem Sump Tube, Sherwood Medical Co. (1983). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K073003: Syngo Dual Energy with Extended Functionally (2008), 168 descendants of its own
- K083524: Syngo Dual Energy with Extended Funationally (2009), 117 descendants of its own
- K112020: Syngo.CT Vascular Analysis (2011), 99 descendants of its own
- K123920: Syngo.Via (2013), 63 descendants of its own
- K093621: Syngo.Pet&CT Oncology (2010), 54 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 im 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

Source page: https://510kreport.com/device/K062351
Methodology: https://510kreport.com/methodology