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510(k) Data Aggregation

    K Number
    K120551
    Device Name
    SIMUPLAN TREATMENT PLANNING SYSTEM
    Manufacturer
    Date Cleared
    2012-06-08

    (106 days)

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

    SIMUPLAN S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.
    Device Description
    The SIMUPLAN Treatment Planning System is computer based software that runs on a Macintosh platform. The modified device, SIMUPLAN Treatment Planning System version 8.5, is a stereotatic radiosurgery module update only. The planning process begins with the selection of the treatment machine (linear accelerator) and the image set that will be used for treatment planning. The patients' image sets (i.e. CT, MR, etc.) are imported into the system by standard methods: DICOM, disk, etc. From this data the stereotatic frame is localized and the patients' anatomical structures and tumor site are contoured. The treatment plan will be calculated from the target volume, isocenter, treatment machine and prescription dose and a dose distribution will be displayed. This treatment plan can be modified by the physician prior to final output and patient treatment. The physician approved treatment plan is then printed out and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved under a unique file name in the patient database. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.
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    K Number
    K093391
    Device Name
    SIMUPLAN TREATMENT PLANNING SYSTEM
    Manufacturer
    Date Cleared
    2009-12-23

    (54 days)

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

    SIMUPLAN S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.
    Device Description
    The SIMUPLAN Treatment Planning System is computer based software that runs on a Maclitosh platform. The planning system is comprised of 2 main components; external beam and bracilytheray. The modified device, SIMUPLAN Treatment Planning System version 8.4 software included in this colors and module update only. The external beam software not included in this release. With the brachytherapy module, the patients' image sets (i.e. CT, MR, US or x-ray films), are imported into the system by various methods: DICOM, disk, video, etc. From this data the patients' anatomical structures and tumor site is contoured in order to generate a 3D patient model, or x-ray films are used for 2D reconstruction of the implant area. Following the import of images, the next steps in the process will be to define the treatment machine, reconstruct implant applicators or define template and seed location. From this inframating the user will select the appropriate source (afterloading or seed) to be used for the planning session. Based on the target volume or reconstructed implant, treatment source and prescription dose the treatment plan will be calculated and a dose distribution will be displayed. This treatment plan can be modified by the physician prior to final output and patient treatment. The physician approved treatment plan is then printed out, machine data generated (for remote afterloading) and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved unter a unique file name in the patient database. The program output does not directly treat the patient; all information must be confirmed by the physician prior to treatment.
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    K Number
    K030821
    Device Name
    SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5
    Manufacturer
    Date Cleared
    2003-09-17

    (187 days)

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

    SIMUPLAN S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SIMUPLAN Treatment Planning System is intended for use in preparing individual treatment plans for patients undergoing radiation therapy treatment with external beam or brachytherapy. The program output does not directly treat the patient, all information must be confirmed by the physician prior to treatment.
    Device Description
    SIMUPLAN Treatment Planning System is a computer based software that runs on a MacIntosh platform. The planning system is comprised of 2 main components; external beam and brachytherapy. The patients' transverse slices (i.e. CT, MR) or x-ray films are imported to the system from various methods: DICOM, disk, video, scanner. From this data the patient anatomical structures and tumor site is contoured in order to generate a 3D patient model, or x-ray films displaying the implant area are imported for standard brachytherapy treatment planning. The following step in the process will be to define the treatment machine, applicators, template, seed location, or isocenter. From this information the user will select the appropriate source (brachytherapy) or beam data (linear accelerators) to be used for the planning session. Based on the target volume or reconstructed implant, the treatment source (external beam or radioactive source) and prescription dose the treatment plan will be calculated and a dose distribution will be displayed. The physician is capable of fine tuning this treatment plan before final output. The approved treatment plan is then printed out, a program card written (remote afterloading) and a hard copy of the isodose distribution is prepared for the patients' permanent record. The patient data is then saved under a unique file name in the patient data base. The program output does not directly treat the patient, all information must be confirmed by the physician prior to treatment.
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