Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K042861
    Device Name
    ODYSSEY
    Manufacturer
    PERMEDICS, INC.
    Date Cleared
    2005-01-12

    (89 days)

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

    PERMEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
    Device Description
    The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). The system includes functions for imaging, target and non-target delineation, beam planning, verification and quality assurance. An earlier version of the software was known as "OptiRad" (K993895). In addition to forward planning, users who have the Intensity Modulated Radiation Treatment (IMRT) module can perform inverse planning.
    Ask a Question
    K Number
    K993895
    Device Name
    OPTIRAD
    Manufacturer
    PERMEDICS, INC.
    Date Cleared
    2000-06-02

    (199 days)

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

    PERMEDICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiRad software is to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgement prior to use. The device provides output data in the form of displays and/or hardcopies to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist.
    Device Description
    The OptiRad 3D-radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). Input is user controlled. This treatment planning system does not provide direct or indirect control over any treatment delivery device or system in any form. The OptiRad software application is intended to be used for the computation, display, evaluation, and output documentation of radiation dose estimations that are to be submitted for independent clinical review and verification by a physicist or physician prior to use. The application provides output data in the form of displays or hardcopy printouts to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, dosimetrist, or radiation treatment planner.
    Ask a Question

    Page 1 of 1