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510(k) Data Aggregation

    K Number
    K080970
    Device Name
    USHIFU STEPPER
    Manufacturer
    USHIFU DEVELOPMENT COMPANY, LLC
    Date Cleared
    2008-06-11

    (68 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    USHIFU DEVELOPMENT COMPANY, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The USHIFU Stepper is intended to provide support and stabilization for an ultrasonic probe during prostate imaging.
    Device Description
    The USHIFU Stepper is a mechanical device which is manually controlled in the horizontal and vertical directions. It is designed to allow for finite adjustments in these planes. It is composed of light-weight materials, is pre-assembled and easily attached to a surgical table.
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