# K241757: syngo.CT Dual Energy

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jan 3, 2025 after 199 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: 15 generations back to K954678 (1996). 83 ancestors in all.
1 later device descends 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)
- K232155: syngo.CT Dual Energy, Siemens Medical Solutions USA, Inc. (2023) Summary page 6.

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

## Indications for use
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 1) • Gout Evaluation 1) • Lung Vessels 1) • Heart PBV • Bone Removal • Lung Perfusion 1) • Lung Mono 1) • Liver VNC 1) • Monoenergetic Plus 1) • Virtual Unenhanced 1) • Bone Marrow • Hard Plaques • Rho/Z • 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 Siemens Healthineers Photon-Counting CT scanners acquired in QuantumPlus modes. 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/K241757
Methodology: https://510kreport.com/methodology