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510(k) Data Aggregation

    K Number
    K984196
    Device Name
    MODIFICATION TO PROWESS PRO-SIM
    Date Cleared
    1998-12-11

    (18 days)

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

    SSGI PROWESS SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prowess Pro-Sim is a modularly designed radiation therapy treatment planning computer program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can displayed in 3D prior to treatment.
    Device Description
    The Prowess treatment-planning product is a series of independent software programs used to plan a course of radiation therapy. The treatment plan includes an estimated dose distribution for a patient. The dose is calculated by applying known and tested algorithms. Measured treatment machine data combined with geometric and tissue information, for a particular patient, are processed by the algorithm into a dose distribution. The Prowess Treatment Planning System (TPS) is separated into three major components: 1. Incorporating patient data into a patient model. 2. Creating treatment plans for each set of patient data. 3. Calculating the treatment plans. Pro-Sim TPS has all of the features of Pro-Sim VPS with the dose calculation capability of P3000. In this program the dose distribution can be shown in the 2D and 3D views.
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    K Number
    K980379
    Device Name
    PROWESS PRO-SIM
    Date Cleared
    1998-05-18

    (108 days)

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

    SSGI PROWESS SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Prowess Pro-Sim is a modularly designed Radiation Treatment Planning Computer Program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can be simulated using Prowess Pro-Sim in 3D on the computer's display prior to actual treatment.
    Device Description
    The Prowess treatment-planning product is a series of independent software programs that are used to plan a course of radiation therapy. The treatment plan is an estimated dose distribution for a patient. The dose is computed by applying known and tested algorithms. Measured treatment machine data combined with geometric and tissue information, for a particular patient, are processed by the algorithm into a dose distribution. The TPS software is designed to run on a personal computer (PC). Depending on the configuration of the program, the PC requires one of the following operating system: Windows NT, DOS or DOS under Windows-95. Other system components and peripherals include: 160 Mb of RAM, high resolution graphics display video card, network card, printer, plotter, digitizer, 3.5 inch floppy disk and tape backup drives.
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