LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250060
    Device Name
    GT300; GT300-C
    Manufacturer
    GENORAY CO., LTD.
    Date Cleared
    2025-10-08

    (271 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K200469
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    It is intended to produce 2D (panoramic, cephalometric) or 3D (Cone Beam Computed Tomography) images. It provides diagnostic details of the dental-maxillofacial, TMJ and SINUS for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment.

    Device Description

    GT300 & GT300-C is the Diagnostic computed tomography limited view field X-ray System which consists of image acquisition modes; panorama, cephalometric, and computed tomography. It is used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments.

    This equipment is a device that generates and controls X-rays and consists of an X-ray generator, an X-ray control unit, an X-ray support unit, and some accessories (Chinrest, Exposure switch, Temple support, Carpus Plate).

    GT300 and GT300-C have same intended use, essential design and manufacturing. The GT300 can acquire panoramic and CT images, while the GT300-C can acquire panoramic, CT, and Cephalo images. The only difference is the presence or absence of the Cephalo feature.

    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1