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510(k) Data Aggregation

    K Number
    K252110

    Validate with FDA (Live)

    Device Name
    Dental X-RAY Unit (AJX200)
    Manufacturer
    Guangzhou Ajax Medical Equipment Co., Ltd.
    Date Cleared
    2026-03-12

    (248 days)

    Product Code
    EHD
    Regulation Number
    872.1800
    Type
    Traditional
    Panel
    Radiology
    Age Range
    0 - 150
    Reference & Predicate Devices
    K200182
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Unit is an extraoral source dental radiographic x-ray unit. This unit works as diagnostic purpose x-ray source for human teeth with resultant image recorded on intraoral dental x-ray film or image receptor. The unit is intended to be used in a dental hospital or general hospital with a dental office and should have a separate space to install and use this product. The device is intended to be used for adult and pediatric patients.

    Device Description

    The equipment acquires images by emitting X-rays continuously on a human tooth. X-rays are emitted when high voltage is supplied to the X-ray tube assembly, which frees electrons from the cathode. They hit the anode to produce X-rays.

    AI/ML Overview

    N/A

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