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510(k) Data Aggregation

    K Number
    K213891
    Device Name
    RealNow
    Date Cleared
    2023-02-24

    (437 days)

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

    YIWEI Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RealNow is an image processing software package to be used by trained professionals including physicians. The software runs on a standard "off-the-shelt" computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, analysis and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM compliant imaging devices. RealNow provides viewing, analysis and communication capabilities for functional and dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated in the standard DICOM format and may be viewed on existing radiological imaging viewers.
    Device Description
    RealNow image analysis includes calculation of the following perfusion related parameters: - Cerebral Blood Flow (CBF) - Cerebral Blood Volume (CBV) - Mean Transit Time (MTT) - Residue function time-to-peak (TMax) - Arterial Input Function (AIF) The primary users of RealNow are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by RealNow should be viewed through appropriate diagnostic viewers when used in clinical decision making.
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