# K073003: Syngo Dual Energy with Extended Functionally

- Pathway: 510(k) (Special)
- Applicant: Siemens Medi Cal Solutions, Inc.
- Decided: Feb 7, 2008 after 106 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: 6 generations back to K954355 (1995). 27 ancestors in all.
168 later devices descend from it; 2 cite it directly.
1 of 196 devices in its family (counting itself) has 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.
- K052029: Syngo Circulation, Siemens AG Medical Solutions (2005) Summary page 2.
- K071513: Inspace 4D Software Package with Extended Functionality, Siemens Medical Solutions (2007) Summary page 2.
- K062673: Modification to Syngo Inspace 4D, Siemens AG Medical Solutions (2006) Summary page 2.

## Most influential descendants
- 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
- K150843: syngo®.via (version VB10A) (2015), 46 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 has been extended with additional applications.

Source page: https://510kreport.com/device/K073003
Methodology: https://510kreport.com/methodology