# K251805: syngo.CT Dual Energy

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 15, 2025 after 125 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: 16 generations back to K954678 (1996). 84 ancestors in all.
No later device cites it as a predicate yet.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241757: syngo.CT Dual Energy, Siemens Medical Solutions USA, Inc. (2025) Summary page 6.

## 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: • Bone Marrow 2) • Bone Removal 1) • Brain Hemorrhage 1) • Gout Evaluation 1) • Hard Plaques 1) • Heart PBV • Kidney Stones 1) 2) 3) • Liver VNC 1) • Lung Mono 1) • Lung Perfusion 1) • Lung Vessels 1) • Monoenergetic 1) 2) • Monoenergetic Plus 1) 2) • Optimum Contrast 1) 2) • Rho/Z 1) 2) • SPP (Spectral Post-Processing Format) 1) 2) • SPR (Stopping Power Ratio) 1) 2) • Virtual Non-Calcium (VNCa) 1) 2) • Virtual Unenhanced 1) The availability of each feature depends on the Dual Energy scan mode. 1) This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes. 2) This functionality supports data from Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPeak modes. 3) 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/K251805
Methodology: https://510kreport.com/methodology