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510(k) Data Aggregation

    K Number
    K962080
    Device Name
    RPS-50 BEAM SCANNER
    Date Cleared
    1996-08-23

    (87 days)

    Product Code
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    SOFIELD SCIENCE SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RPS-50 is intended to be used as an accessory to a linear accelerator under the direct control of a qualified individual (usually a therapeutic radiation physicist.) The scanner may be used for acceptance testing of new accelerators, quality control of existing accelerators, or for the collection of data necessary for the operation of a computerized treatment planning system.
    Device Description
    The RPS-50 scanner consists of a water tank, linear scanning guides, electronic control of movement, chamber bias, and system gain control. A software program controls all movements and necessary electronic signals. The scanner moves a radiation detector through a field of high radiation and presents the collected data as a plot on a computer screen, as a table of data or on a floppy disk suitable for use in a treatment planning system.
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