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510(k) Data Aggregation
(125 days)
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.
Dual energy offers functions for qualitative and quantitative post-processing evaluations. syngo.CT Dual Energy is a post-processing application consisting of several post-processing application classes that can be used to improve the visualization of the chemical composition of various energy dependent materials in the human body when compared to single energy CT. Depending on the organ of interest, the user can select and modify different application classes or parameters and algorithms.
Different body regions require specific tools that allow the correct evaluation of data sets. syngo.CT Dual Energy provides a range of application classes that meet the requirements of each evaluation type. The different application classes for the subject device can be combined into one workflow.
The product is intended to be used for at least 21-year-old humans.
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