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510(k) Data Aggregation

    K Number
    K980904
    Device Name
    MUCHECK MONITOR UNIT VALIDATION PROGRAM
    Manufacturer
    MEDICAL DOSIMETRY SERVICES, INC.
    Date Cleared
    1998-06-08

    (90 days)

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

    MEDICAL DOSIMETRY SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the muCheck Monitor Unit Validation Program is the same as for the predicate device: to calculate a monitor unit or timer setting for the purpose of validating a monitor unit or timer setting previously calculated by a primary radiation treatment planning system or hand calculation. The intended use is as a quality assurance tool only and not as a treatment planning device.
    Device Description
    The muCheck Monitor Unit Validation Program is a software program that is designed to operate on an IBM compatible personal computer in a Windows environment. It has been designed to operate on a stand alone mode independent of any radiation treatment planning system. It does not connect to or control any radiation hardware device.
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