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    K Number
    K131777
    Device Name
    HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
    Manufacturer
    HYPER TECHNOLOGY INC
    Date Cleared
    2014-02-28

    (256 days)

    Product Code
    IWB
    Regulation Number
    892.5750
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYPER TECHNOLOGY INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hyper Source-unit Rotating Gamma System (SGS-1+) is a teletherapy device indicated for use in stereotactic irradiation of intracranial structures.
    Device Description
    The Hyper Source-unit Rotating Gamma System (SGS-1+) consist of Main Mechanical System, Localization Device, Control System, Therapy Planning System (TPS) etc.
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