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    K Number
    K233076
    Device Name
    Laser Speckle Imaging System (RFLSI CZW)
    Manufacturer
    RWD Life Science Co., Ltd.
    Date Cleared
    2024-05-28

    (245 days)

    Product Code
    DPT
    Regulation Number
    870.2120
    Why did this record match?
    Applicant Name (Manufacturer) :

    RWD Life Science Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use.
    Device Description
    The Laser Speckle Imaging System (RFLSI CZW) is intended for blood flow measurements in the micro-circulation. This device is intended for clinical research use. It is a measurement tool based on the laser speckle contrast analysis technology and provides real-time blood perfusion information of tissue and organs in a visual and quantitative way. The device is non-patient contacting and does not require the use of contrast agents.
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