# K133648: Syngo, CT Dual Energy

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jul 7, 2014 after 222 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.
16 later devices descend from it; 2 cite it directly.
0 of 65 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.
- K837107: Somatom Dri X-Ray CT Scanner, Siemens Medical Solutions USA, Inc. (1983) Summary page 2.

## Most influential descendants
- K150757: syngo.CT Dual Energy (2015), 13 descendants of its own
- K150745: syngo.CT Single Source Dual Energy (2015), 11 descendants of its own
- K153220: syngo.CT Single Source Dual Energy (Twin Beam) (2016), 6 descendants of its own
- K173625: syngo.CT Clinical Extensions (2018), 5 descendants of its own
- K163289: syngo. CT Single Source Dual Energy (twin beam) (2017), 5 descendants of its own

## Indications for use
syngo.CT Dual Energy is designed to operate with CT images which have been acquired with Siemens Dual Source scanners. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. Depending on the region of interest, contrast agents may be used. These differences provide information on the chemical composition of the scanned body materials. syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize this information. The functionality of the syngo.CT Dual Energy applications is as follows: Monoenergetic; Lung Perfusion; Brain Hemorrhage; Liver VNC; Gout Evaluation; Monoenergetic Plus; Lung Vessels; Virtual Unenhanced; Heart PBV; Bone Marrow; Bone Removal; 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/K133648
Methodology: https://510kreport.com/methodology