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510(k) Data Aggregation

    K Number
    K031088
    Device Name
    TRIMED PLAN, VERSION 2.2
    Date Cleared
    2004-07-23

    (476 days)

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

    TRIMED SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    TriMed Plan is a radiation treatment planning software developed by TriMed Systems, Inc, running on IBM compatible personal computers with Microsoft Windows operating systems. TriMed Plan provides radiation treatment planning capability, for both photon and electron external beam sources, to satisfy the prescription of the radiation oncology. Tribed Plan uses 3D conformal therapy treatment approaches to combine modality plans, I rimed I har asso on-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges. The resulting treatment plan from this system is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.
    Device Description
    TriMed Plan is a comprehensive 3D radiation treatment planning system for modeling dose distribution of radiation of patient undergoing photon or electron therapy based on modern personal workstation running Windows NT, Windows 2000 and Windows XP. External beam dose calculations for both photon and electron machines are all in 3-dimensional volume that support coplanar and non-coplanar fields. Beam modifiers include hand block, customized block, multi-leaf collimators, and wedge. Different energies and modalities can be combined into the same plan. State-of-the-art 2D/3D graphics user interface makes the system very user friendly.
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