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510(k) Data Aggregation

    K Number
    K193381
    Device Name
    RadCalc Software
    Manufacturer
    LifeLine Software, Inc.
    Date Cleared
    2019-12-31

    (26 days)

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

    LifeLine Software, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RadCalc has the following intended uses: 1. RadCalc performs a secondary dose calculation verification on the treatment plan done by the treatment planning software. This is RadCalo's primary function. Radiation therapy systems typically calculate the monitor units needed to deliver the desired amount of radiation to a point of reference within the patient. In this situation, RadCale will serve to validate those monitor units computed by the primary radiation therapy planning system. Additional verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. It is not the intention of RadCalc to replace the calculation performed by the primary radiation therapy planning computer but to validate its calculation as a means of quality assurance. The practice of performing a secondary check is recommended by the American Association of Physicis in Medicine (AAPM) Task Group 40 as part of a good quality assurance program. This practice is an important aspect in providing quality patient care. 2. Import data from the treatment planning software and export the treatment planning system to the verify and record system, which is the device that actually controls the radiation beam. This will reduce the number of errors that occur as a result of manually inputting this data. 3. In addition to performing the secondary dose verification calculation, RadCalc can also be used as the primary means of calculating monitor units in situations where the physician does not order the use of a radiation therapy treatment plan. RadCalc can independently calculate the amount of radiation the beam should produce (called the MU or monitor unit) to deliver to the patient the radiation dose the doctor recommends. This function is usually only used in urgent, emergency situations. 4. In addition, RadCalc performs brachytherapy-type calculations. For brachytherapy calculations, High Dose Rate (HDR), Low Dose Rate (LDR), and Permanents can be verified. Verification activities revolve around point dose comparisons, 3D dose evaluation via Gamma analysis, and DVH comparisons. RadCalc is not used as a primary means of calculating patient dose for brachytherapy treatments. 5. Analysis of fluence and dose maps can be percentage difference, distance to agreement, or gamma analysis methodologies. 6. Interoperability with external dose calculation engines (EDCE) by sending them treatment plans and associated information in their necessary format so that the EDCE can perform a 3D dose calculation using its dose calculation algorithm. The computed dose volume is received back and the 3D analysis tools described above are used to compare against the treatment planning system.
    Device Description
    Not Found
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    K Number
    K090531
    Device Name
    RADCALC SOFTWARE, VERSION 6.0
    Manufacturer
    LIFELINE SOFTWARE, INC.
    Date Cleared
    2009-05-27

    (89 days)

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

    LIFELINE SOFTWARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RadCalc Software is a program utilized in a radiation therapy department for the determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. For external beam treatments, RadCalc's monitor unit calculation can be used to validate the monitor units or dose previously determined by hand or by the primary radiation therapy planning system. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc Software not only performs this secondary function but can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan. RadCalc Software imports treatment planning parameters from the primary treatment planning system or a verify and record system; parameters can also be entered manually. The dosimetric calculations are then performed for photon or electron external beam radiation plans or LDR, HDR, and Permanent Implant brachytherapy treatment plans. The brachytherapy treatment module is only used to validate the dose to points of interest and not for brachytherapy treatment planning. RadCalc Software allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system (system actually controlling the radiation beam) to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data.
    Device Description
    The RadCalc Software is a stand-alone program or operating from a server that provides determination of monitor units and/or the dose to various points of interest for external beam radiation therapy and/or brachytherapy treatments. RadCalc is designed to work on personal computers in a Windows operating system that is connected directly to the primary radiation therapy planning system. The program makes the task of performing independent Monitor Unit validations much faster, easier, and more accurate. RadCalc determines the monitor units or dose through the process of looking data up from previously input tables or data curves. RadCalc's function is to support the primary radiation therapy planning computer by validating its calculation as a means of quality assurance. RadCalc can also be used as the primary means of calculating monitor units for external beam radiation treatments in situations where the physician does not order the use of a radiation therapy treatment plan. RadCalc allows for the transfer of the treatment planning data from the primary radiation therapy planning computer or the Verify and Record system to RadCalc and then to the facility's Verify and Record system or radiation therapy planning computer. This electronic transfer of treatment planning data reduces the number of errors that could occur as a result of manually inputting the data. The software does not control any radiation hardware device, but does interface with the primary radiation therapy planning software and the Verify and Record software.
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    K Number
    K010464
    Device Name
    RADCALC, MODEL V.4.0
    Manufacturer
    LIFELINE SOFTWARE, INC.
    Date Cleared
    2001-05-17

    (90 days)

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

    LIFELINE SOFTWARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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