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510(k) Data Aggregation

    K Number
    K192912
    Device Name
    AutoMIStar
    Date Cleared
    2019-12-31

    (77 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Apollo Medical Imaging Technology Pty. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AutoMIStar is a medical image post-processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shel" computer or a virtual platform with Windows operating system, and can be used to perform image viewing, processing and analysis of brain images acquired by DICOM compliant imaging devices. AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module. The CT Perfusion Module is used for visualization and analysis of contrast enhanced CT Perfusion (CTP) dataset, showing properties of changes in contrast over time. This function includes calculation of various parameters related to tissue flow (perfusion) and tissue blood volume. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
    Device Description
    AutoMIStar is a software package that provides visualization and processing of medical imagesacquired by CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scanners, as an aid to physician diagnosis. It can be installed and run on a PC, laptop or virtual machine running a Microsoft Windows operating system. It provides viewing, quantification, analysis and reporting capabilities. AutoMIStar also provides processing and analysis of functional and dynamic imaging datasets including CT Perfusion (CTP) and diffusion-weighted MRI (DWI). It provides tools to perform the following type of advanced analysis: - time intensity plots for dynamic time courses; - volumetry of threshold maps; - calculation of mismatch between volumes of different threshold maps; AutoMIStar can be configured to connect to various DICOM devices (modality scanners, workstations, PACS) via the hospital medical imaging network to receive CT or MRI images as they become available. It supports transfer of DICOM images using the DICOM standard network protocol, and allows import of DICOM images from storage media. It provides automated workflow to processes received data and sends post-processed results to designated DICOM devices. It can also be configured to send post-processed results to designated recipients via email through the hospital email system. AutoMIStar is a DICOM-compliant PACS softwarethat provides functionality to transfer, process, and display of CT and MR imaging data including dynamically acquired CT perfusion imaging data and diffusion-weighted MRI (DWI). AutoMIStar runs on a standard "off-the-shelf" computer with Windows operating system, and can seamlessly integrate into an existing radiological data network. AutoMIStar is entirely independent from CT, MRI, or PACS platforms.
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