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510(k) Data Aggregation

    K Number
    K251842

    Validate with FDA (Live)

    Device Name
    Dental Computed Tomography X-ray System
    Manufacturer
    Fussen Technology Co.,Ltd.
    Date Cleared
    2025-11-13

    (150 days)

    Product Code
    OAS
    Regulation Number
    892.1750
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K230985
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The product is intended to produce X-ray Cone-Beam Computed Tomography, Panoramic tomography and Cephalometric (optional) images. The medical institutions can use the images for diagnostic purposes in oral and maxillofacial regions. The product is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician.

    Device Description

    The device is used for X-ray image diagnosis of oral and maxillofacial region in medical institutions through X-ray cone-beam computed tomography, panoramic and cephalometric photography. The device is intended for use in hospitals and clinics, operated and used by trained professionals under the guidance of a physician.

    This device is divided into two models: Matrix 7000(Rubik X1), Matrix 7800(Rubik X3).

    The device is composed of X-ray tube head, plate detector, control device, positioning aid, frame, cephalometric positioning shooting aid, workstation software, etc.

    AI/ML Overview

    N/A

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