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510(k) Data Aggregation

    K Number
    K071636
    Device Name
    CODIAGNOSTIX (R) 5.72
    Manufacturer
    IVS SOLUTIONS AG
    Date Cleared
    2007-08-09

    (55 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    IVS SOLUTIONS AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    coDiagnostix® is intended for use by medical trained people as a Windows®- based diagnosis and implant planning software. This software is an interface for the transfer of imaging information from medical scanners such as CT or DVT scanners and also a pre- operative software for simulation dental implant placement and surgical treatment options. The patient population will be the general public. coDiagnostiX® is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices. It's possible to use coDiagnostiX® as a pattern for manufacturing drilling templates with conventional rotary tables or the gonyX® table from IVS Solutions AG in laboratory environment. This drilling template is then used in direct contact with the patient to realize the implant planning with coDiggnostiX®.
    Device Description
    coDiagnostiX® is designed for diagnosis of 3dimensional datasets and precise image- quided and reproducible pre- operative planning of dental implants. The software will be provided either as station version, client or server version. Basically, patient's medical image data from different sources like CT (computer tomography) - or DVT (Digital Volume Tomography resp. NewTom) scanner will be read in with the coDiggnostix® DICOM transfer module, transferred into 3dimensional datasets and stored in a database. The succeeded planning is realized through the calculation of special views, the analysis of graphic data and the placement of dental implants. For assistance of the planning procedure, several functions are available: - Active measurement tools (length and angle) for individual measuring of implant positions - - Nerve module for distinguishing the behaviour of the nervus mandibularis channel - - -3D Cut for a 3dimensional cut through the jaw for fine adjustment of the implant position - -Segmentation module for coloring several areas inside the slice dataset (e.g. jaw bone, natural tooth series) or kinds of tissue (e.g. bone, skin) and creating a 3D reconstruction of the dataset - -Parallelizing function for adjustment of adjacent images - -Bone densitometry with a density statistic for density measuring in the area around the positioned implant; a density allocation along the and transverse to the implant cover area is displayed All working steps will be saved automatically to the actual plan of the patient. For each patient several plans are possible to generate several proposals, so that the dentist or lab is free to choose the ideal proposal for generating an according drilling template needed for realization of the planning during the main operation. As in the station version of the coDiognostiX® software all functions are available, the client version needs the patient data provided by the server version.
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