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510(k) Data Aggregation

    K Number
    K221627
    Device Name
    PerfusionGo Plus
    Date Cleared
    2023-01-19

    (227 days)

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

    Yukun (Beijing) Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    PerfusionGo Plus is an image 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-shelf" computer, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.
    Device Description
    PerfusionGo Plus is a standalone software package that is comprised of several modules including Login Module, Image List Module, Image Processing Module and Management Configuration Module. PerfusionGo Plus allows a DICOM-compliant device to send files directly from the image modality, through a node on a local network, or from a PACS server. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM. Following such analysis, the results of analysis can be exported manually. The software allows for repeated use and continuous processing of data and can be deployed on a supportive infrastructure that meets the minimum system requirements. PerfusionGo Plus image analysis includes calculation of the following perfusion related parameters: - Cerebral Blood Flow (CBF) - Cerebral Blood Volume (CBV) - Mean Transit Time (MTT) - Time-to-peak (TTP) - Residue function time-to-peak (Tmax) - Time-density curve (TDC) The primary users of PerfusionGo Plus are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by PerfusionGo Plus should be viewed through appropriate diagnostic viewers when used in clinical decision making.
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