syngo.CT Dual Energy is a post-processing software application for CT scans that uses dual-energy imaging techniques combining low and high energy X-ray spectra to enhance visualization of different materials in the body. It helps clinicians by providing advanced imaging features for better evaluation of anatomical structures and pathologies, including brain hemorrhage visualization, lung perfusion, kidney stone analysis, and more, improving diagnostic accuracy without requiring additional scans.
syngo.CT Dual Energy combines images acquired with low and high energy spectra to visualize chemical composition differences of scanned body materials. Depending on the region, contrast agents may be used.
Post-processing software application performing qualitative and quantitative evaluations by combining dual-energy CT images to improve visualization of chemical composition, supporting several application classes tailored to different organs, including support for Siemens Photon-Counting CT scanners in QuantumPlus mode.
Performance evaluation included two-reader studies validating clinical performance on photon-counting CT and dual-source dual-energy CT data for brain hemorrhage, lung analysis, and kidney stone visualization, demonstrating agreement with follow-up data and conventional CT findings, with risk analysis and software verification supporting device safety and effectiveness.
No predicate devices specified
Submission
6/18/2024
FDA Approval
1/3/2025
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