Intended Use

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.

Technology

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

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.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    6/18/2024

    6 months
  • 2

    FDA Approval

    1/3/2025

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