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    K Number
    K180989
    Device Name
    PEDRA-17F Digital Flat Panel X-ray Detector
    Manufacturer
    Radisen Inc.
    Date Cleared
    2018-06-13

    (58 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radisen Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PEDRA-17F detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
    Device Description
    Not Found
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