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510(k) Data Aggregation

    K Number
    K241819
    Device Name
    CephNinja
    Manufacturer
    Date Cleared
    2025-01-23

    (213 days)

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

    Cyncronus LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CephNinja 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. Mobile application is not for diagnostic use.
    Device Description
    CephNinja 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, conduct cephalometric analysis, and view cephalalometric results. CephNinja is imaging software designed for use in dentistry. The main CephNinja software functionality includes image visualization and cephalometric tracing and measurements. CephNinja is used by dental professionals 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 image file (specifically, a lateral cephalometric x-ray) has been imported into the software, the software can be used 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. The software operates on standard Mac/iMac (OS Big Sur M1) hardware, and when not used for diagnostic purposes, iPhone/iPad (OS 9.0 or higher) hardware. When iMac hardware is used, images are displayed on the connected display/monitor. CephNinja is a standalone product.
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