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510(k) Data Aggregation

    K Number
    K223780
    Device Name
    Lumos 3DX
    Manufacturer
    Date Cleared
    2023-07-06

    (202 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    3Dio

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lumos 3DX ™ System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jav, and other oral structures. The system provides 3D imaging for diagnostic purposes via tomosynthesis. For use on adult patients only.
    Device Description
    The Lumos 3DX system is a 3D dental chairside X-ray system on a mobile stand that uses tomosynthesis (limited-angle tomography) to generate 3D images of the teeth and surrounding structures. A custom digital sensor is placed in the patient's mouth and multiple images are acquired around an arc of rotation and then fed into a 3D reconstruction algorithm. The digital sensor provided with the system is specifically for use with the Lumos 3DX device. The sensor has a higher frame rate that enables the Lumos 3DX system to capture 30 images in a short period of time. A server is provided as part of the Lumos 3DX system and wirelessly connects to one or more Lumos 3DX systems. After capturing images, the Lumos 3DX wirelessly transfers them to the server for reconstruction. This server can then be connected to the local network for access of the reconstructed data.
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