Siemens Medical Solutions USA, Inc. · Class II · Cleared Jan 3, 2025
| K-number | K241757 |
| Device name | syngo.CT Dual Energy |
| Applicant | Siemens Medical Solutions USA, Inc. |
| Product code | JAK |
| Device class | Class II |
| Decision date | Jan 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1750 |
syngo.CT Dual Energy is a post-processing software application for computed tomography that visualizes the chemical composition of anatomical regions by combining images acquired at low and high energy spectra. It provides multiple application classes for tasks such as brain hemorrhage evaluation, lung vessel and perfusion analysis, kidney stone characterization, virtual unenhanced imaging, and bone marrow visualization, with availability of specific features depending on the dual energy scan mode used.
The subject device (VB80) adds support for photon-counting CT scanner data in QuantumPlus modes for brain hemorrhage and lung analysis applications, introduces a new Lung Mono image type for dual source and photon-counting modes, expands Monoenergetic Plus and Bone Marrow to accept dual source dual energy data from photon-counting scanners in QuantumPeak mode, adds Dual Spiral/Twin Spiral scan-mode support for Virtual Unenhanced, and adds Kidney Stones support for photon-counting data. The core algorithms, visualization methods, and operating platform remain unchanged from the predicate.
The device meets FDA-recognized consensus standards including ANSI AAMI IEC 62304:2006/A1:2016 (software life cycle), NEMA PS 3.1-3.20 2022d (DICOM), ISO 14971:2019 (risk management), IEC 62366-1 Edition 1.1 2020-06 (usability engineering), ISO 15223-1 Fourth edition (symbols), and ISO 20417:2021 (manufacturer information).
Substantial equivalence is established because the subject device has identical intended use and indications as the predicate device (syngo.CT Dual Energy VB71), no changes in fundamental scientific technology or core operating principles, and the same technological characteristics regarding image visualization, platform, and measurement capabilities. The modifications represent functional enhancements to support additional scanner data formats (photon-counting CT modes) and new output image types derived from existing algorithms, while the underlying dual-energy decomposition methodology remains unchanged. Performance testing demonstrated that new features (Brain Hemorrhage, Lung Analysis, Lung Mono for photon-counting data) perform as intended with clinically acceptable results consistent with the predicate device's performance.
View the full FDA submission: accessdata.fda.gov