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510(k) Data Aggregation

    K Number
    K982821
    Device Name
    MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7
    Manufacturer
    MULTIMEDIA MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-11-05

    (86 days)

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

    MULTIMEDIA MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MMS . TherpacPLUS B3DTUI is a software application for pre-operative planning and post-operative evaluation of permanent implant brachytherapy procedures for the treatment of prostate cancer. It assists physicians and medical physicists in pre-olanning the patient's implant procedure and evaluating the actual post-operative results of the procedure.
    Device Description
    Hardware Platform and Operating System: The application runs on standard Intel PCs under Microsoft Windows® 32-bit operating systems. The application is available on an OR-safe hardware platform. This hardware platform has electrical safety, emission control and cleaning provisions. Peripherals and Accessories: The application interfaces with an electromagnetic digitizer, video capture cards, printers, film scanners, as well as DICOM and other image importer and data drives and external sources. Software Features: The application supports image capture and importation from clinical imaging modalities sources, structure contouring and template registration, seed placement and dosimetry display for procedure planning and post-plan evaluation. Planning functions are supported by auto seed placement and dose optimization routines. The application supports post-procedure evaluation through automatic seed identification. Both planning and evaluation functions allow plans to be printed on reports, support visualization in 2D and 3D views. The applications has two user support modules - seed source specification and database manager.
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