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510(k) Data Aggregation

    K Number
    K243005
    Device Name
    AudaxCeph Cephalogram Analysis Software
    Manufacturer
    Date Cleared
    2025-05-30

    (246 days)

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

    Audax d.o.o.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    AudaxCeph Cephalogram Analysis Software is designed for use by specialized dental practices for storing and presenting patient images and assisting in treatment planning. Results produced by the software's treatment planning tools are dependent on the interpretation of trained and licensed practitioners.
    Device Description
    AudaxCeph Cephalogram Analysis Software is a software-only device intended for use by specialty dental professionals in the development of 2D dental treatment planning utilizing cephalogram landmarks. Cephalogram imagery must be captured separately and inputted to the program using a variety of common file formats (BMP, JPG, JPEG, PNG, TIFF). Landmarks are digitized, structures are traced, measurements can be taken, and various custom analysis types are possible. The software assists in orthodontic treatment planning by providing image analysis, superimpositions, and VTO (visualized treatment objective). The software is offered in two different client configurations: A desktop client as an application locally-hosted on a PC ("AudaxCeph Ultimate" and "Essentials"), and a cloud-hosted solution ("AudaxCeph WeDoCeph") which is accessible by a web browser client. Both are intended for use only by specialty dental professionals, have no patient-interacting components or interfaces, and all analysis capabilities of the AudaxCeph Cephalogram Analysis software that inform clinical decisions are within the capabilities of the CephX Cephalometric Analysis Software predicate device.
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