# K232155: syngo.CT Dual Energy

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Nov 30, 2023 after 133 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: 14 generations back to K954678 (1996). 82 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212889: Syngo.CT Dual Energy, Siemens Medical Solutions USA, Inc. (2022) Summary page 6.

## Most influential descendants
- K241757: syngo.CT Dual Energy (2025), 1 descendant of its own
- K251805: syngo.CT Dual Energy (2025), 0 descendants of its own

## Indications for use
syngo.CT Dual Energy is designed to operate with CT images based on two different X-ray spectra. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. 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. Depending on the region of interest, contrast agents may be used. The general functionality of the syngo.CT Dual Energy application is as follows: * Monoenergetic 1) * Brain Hemorrhage * Gout Evaluation 1) * Lung Vessels * Heart PBV * Bone Removal * Lung Perfusion * Liver VNC 1) * Monoenergetic Plus 1) * Virtual Unenhanced 1) * Bone Marrow * Hard Plaques * RholZ * Kidney Stones 1) 2) * SPR (Stopping Power Ratio) * SPP (Spectral Post-Processing Format) 1) * Optimum Contrast 1) The availability of each feature depends on the Dual Energy scan mode. 1) This functionality supports data from Photon-Counting CT scanners. 2) 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 upon consideration of all available information. The accuracy of identification is decreased in obese patients.

Source page: https://510kreport.com/device/K232155
Methodology: https://510kreport.com/methodology