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510(k) Data Aggregation

    K Number
    K190162
    Device Name
    SmartCeph
    Manufacturer
    Date Cleared
    2019-10-17

    (259 days)

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

    Ortho2, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SmartCeph software is designed for use by dental practices for cephalometric tracing and presenting patient images which are utilized by dental professionals to assist in treatment planning and case diagnosis. Results produced by the software's diagnostic and treatment planning tools are dependent on the interpretation of trained and licensed dental practitioners.
    Device Description
    SmartCeph is a software-only dental image device which allows the user to digitize landmarks on a patient's digital lateral cephalometric x- ray image, trace cephalometric structures, view cephalometric measurements, and superimpose images for analysis and presentation. SmartCeph is imaging software designed for use in dentistry. The main SmartCeph software functionality includes image visualization, cephalometric tracing and measurements. SmartCeph is used by dental professional for the visualization of patient images retrieved from a dental cephalometric imaging device scanner for assisting in case diagnosis, review and treatment planning for orthodontic and orthognathic applications. If a suitable JPEG image (specifically, a lateral cephalometric x-ray) has been imported into the software, the software can be utilized to define a number of structures and landmarks to establish specific anatomical features. The positions of specific landmarks are used to render tracing lines and calculate measurements used in orthodontic treatment planning. If multiple x-ray images for which cephalometric data has been digitized are imported, the resulting tracings can be overlaid to indicate changes and/or differences in the anatomy. The software operates upon standard Windows PC hardware and displays images on the PC's connected display/monitor. SmartCeph is a standalone product but is designed to work cooperatively with Ortho2's dental practice management software that is used for scheduling and billing.
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