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Intended Use

syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners). Resulting images can be used to assist trained technicians or physicians in diagnosis.

Technology

It is a software bundle offering multiple extensions (e.g., Trauma, Interactive Spectral Imaging, Vascular, Osteo, Neuro DSA, Dual Energy, Pulmonary Density) to create advanced visualizations and measurements on clinical data acquired by CT and possibly MR scanners. Modifications include support for larger images and additional data sets, with AI-enabled lung opacity segmentation.

Performance

Non-clinical integration and functional testing were conducted during product development to verify that the features perform as intended, with risk analysis and mitigation. Testing validated all software specifications met acceptance criteria, supporting claims of substantial equivalence to predicate devices.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/22/2021

    29 days
  • 2

    FDA Approval

    1/20/2022

Other devices from Siemens Medical Solutions USA, Inc.

View all 68 devices

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