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510(k) Data Aggregation

    K Number
    K102583
    Device Name
    MUCHECK, VERSION 9.0
    Manufacturer
    ONCOLOGY DATA SYSTEMS, INC.
    Date Cleared
    2010-11-02

    (55 days)

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

    ONCOLOGY DATA SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system. The intended use of the MuCheck software has been extended to include an optional module, MuCheck/TomoCheck to independently verify the dose for single point that has been previously calculated by the Tomotherapy Hi Art treatment planning system or other points as determined by the physicist.
    Device Description
    The MU Check 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 either in a stand alone mode independent of the treatment planning system or to import plans from the treamment planning system. It does not connect to or control any radiation hardware device. MUCheck performs dose calculations to verify the dose calculated by the primary radiation teament planning system. The functionality of the MUCheck program is being extended to include calculations for the Tomotherapy Hi Art system, by this submission.
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    K Number
    K091602
    Device Name
    MUCHECK V8
    Manufacturer
    ONCOLOGY DATA SYSTEMS, INC.
    Date Cleared
    2009-06-18

    (15 days)

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

    ONCOLOGY DATA SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system. The intended use of the MuCheck software has been extended to include an optional module, Gamma-Knife QA Check to independently verify the dose for single or multiple points that have been previously calculated by the Gamma Knife treatment planning system or other points as determined by the physicist.
    Device Description
    The Gamma-Knife QA Check 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 onerate either in a stand alone mode independent of the Gammaknife treatment planning grown or to import plans from the GammaKnife treatment planning system. It does not connect to a control any radiation hardware device. Gamma Knife QA Check performs dose calculations to verify the dose calculated by the primary GammaKnife radiation treatment planning system.
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    K Number
    K061152
    Device Name
    MUCHECK V7.0
    Manufacturer
    ONCOLOGY DATA SYSTEMS, INC.
    Date Cleared
    2006-05-10

    (14 days)

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

    ONCOLOGY DATA SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In a radiation therapy department, a course of patient treatment is prescribed by a written directive from a radiation oncologist. Certain parameters from this directive are used by the medical dosimetrist and/or medical physicist along with x-rays or CT scans where applicable to plan a course of treatment. Typically a radiation treatment planning system is used to properly define the precise location and dose distribution for the radiation therapy. As part of the planning process monitor unit settings and dose to a volume or specific anatomical points will be generated. The MuCheck - Monitor Unit/Dose validation Software verifies the monitor unit or dose calculated by the primary treatment planning system. MuCheck can also be used to calculate the monitor or dose for simple plans that do not require the use of the primary treatment planning system. The intended use of the MuCheck software has been extended by the addition of an optional module called BrachyCheck. Brachycheck is used to verify brachytherapy procedures(implants using radioactive sources) performed by a brachytherapy treatment planning system. As part of the planning process, dwell positions will be generated and dose contributions from these dwell positions to specified anatomical points will be calculated. The BrachyCheck module (device under review) verifies the dose calculated to the specified points by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation.
    Device Description
    The BrachyCheck Dose Validation module is an optional software module that is part of the MuCheck software. MuCheck is designed to operate on a personal computer in a Windows environment. It has been designed to operate either in a stand alone mode independent of any brachytherapy treatment planning system or to import plans from a brachytherapy treatment planning system. It does not connect to or control any radiation hardware device. BrachyCheck performs dose calculations to verify the dose calculated by the primary radiation brachytherapy treatment planning system.
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    K Number
    K012227
    Device Name
    MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1
    Manufacturer
    ONCOLOGY DATA SYSTEMS, INC.
    Date Cleared
    2001-10-01

    (77 days)

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

    ONCOLOGY DATA SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The muCheck - Monitor Unit Validation Program (the device under review) verifies the monitor unit or dose calculated by the primary treatment planning system. It serves as quality assurance as part of good treatment protocol to have a second means to verify the accuracy of the primary calculation. The Intensity Modulated Radiotherapy and Diode corrections features added to the program to verify dose calculations performed by the primary treatment planning system.
    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. MuCheck performs monitor unit and dose calculations to verify the monitor unit and dose calculated by the primary radiation treatment planning system.
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