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510(k) Data Aggregation

    K Number
    K131348
    Device Name
    ORTOMED
    Manufacturer
    INFOMED SERVICIOS INFORMATICOS S.L.
    Date Cleared
    2014-08-05

    (452 days)

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

    INFOMED SERVICIOS INFORMATICOS S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ORTOMED is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthognathic surgery treatment planning and communication as well as case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.
    Device Description
    Ortomed is an imaging software designed for use by specialized dental practices for capturing, storing and presenting patient's dental images and for assisting in treatment planning and case diagnosis, specifically cephalometric tracing for orthodontic and orthognathic cases. Results produced by the software's diagnostic and treatment planning tools must be interpreted by the trained, licensed practitioner. The software features and capabilities include image and management using the Gesden database and Gesimag image management suite and also specific cephalometric analysis functions and treatment simulation. Features and capabilities include: - Cephalometric landmarking and analysis: lateral, frontal, models and soft profile - - Analysis of models: Bolton, Moyers, Dentoalveolar discrepancy analysis - - Lateral tracing superimposition, overlays on patient images - - -CO/CR conversion, growth forecasts, simulation of facial profile growth - VTO (Visual Treatment Objective) treatment simulation for orthodontic cases - - STO (Surgical Treatment Objective) treatment simulation for orthognathic surgical cases - - -Simulation and display of VTO/STO treatments using warping and morphing.
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