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Intended Use

Rapid is an image processing software package used by trained professionals including physicians and medical technicians to perform image viewing, processing, and analysis of CT and MRI images. Provides viewing and analysis capabilities for functional and dynamic imaging datasets such as CT Perfusion, CT Angiography, and MRI Diffusion Weighted Imaging relevant to acute stroke patient selection.

Technology

Software package that processes DICOM images from CT and MRI sources, providing visualization and analysis of tissue perfusion, diffusion, and contrast changes over time. Can be installed on-premises or accessed virtually, supporting secure connections via VPN or SSH. Incorporates multiple specialized imaging modules to perform advanced analyses, including volumetry, perfusion, mismatch measurement, and vessel density calculation.

Performance

Extensive performance validation testing including software verification and validation confirmed accurate representation of key processing parameters under clinically relevant conditions. Compliance with DICOM standards and risk management per ISO and medical software lifecycle processes was demonstrated, ensuring safety and effectiveness.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/1/2023

    2 months
  • 2

    FDA Approval

    1/16/2024

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