syngo.CT Dual Energy

syngo.CT Dual Energy is a post-processing software application that analyzes CT images acquired at two different X-ray energy levels to visualize the chemical composition of body materials. It provides multiple analysis functions such as bone removal, virtual non-contrast imaging, material characterization (Rho/Z), stopping power ratio calculation, and organ-specific evaluations for brain, liver, lung, and kidney imaging in patients 21 years or older.

The subject device extends the predicate's capabilities by adding support for Photon-Counting CT (PCCT) scanners in QuantumPlus and QuantumPeak scan modes for five application classes: Bone Removal, Hard Plaques, SPR, Rho/Z, and Virtual Non-Calcium. New features include Fat Map and Extracellular Volume (ECV) maps for Liver VNC, and removal of quantitative-use warnings for Brain Hemorrhage and Lung Perfusion on PCCT data. Core image visualization, operating platform, and measurement methodologies remain identical to the predicate.

ANSI AAMI IEC 62304:2006/A1:2016 (software life cycle); NEMA PS 3.1-3.20 2023e (DICOM); ISO 14971:2019 (risk management); IEC 62366-1 Edition 1.1 (usability engineering); ISO 15223-1 Fourth edition (device symbols); ISO 20417:2021 (manufacturer information).

syngo.CT Dual Energy has identical intended use and similar indications as the predicate device. The fundamental scientific technology and technological characteristics (image visualization, operating platform, measurement) are unchanged. Performance testing demonstrates the new PCCT features meet acceptance criteria with accuracy comparable to dual-source dual energy methods. Software verification, validation, and risk analysis confirm all specifications meet requirements, supporting substantial equivalence to the predicate.