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510(k) Data Aggregation

    K Number
    K134055
    Device Name
    ADX4000W
    Manufacturer
    DEXCOWIN CO., LTD
    Date Cleared
    2014-05-09

    (129 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ADX4000W

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADX400W Cordless Portable Dental X-Ray System is indicated for use only by trained and qualified dentists or dental technicians for both adult and pediatic subjects for taking diagnostic extraoral dental x-rays using digital sensors.

    Device Description

    Not Found

    AI/ML Overview

    This document does not contain the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details.

    The provided text is an FDA 510(k) clearance letter for the ADX4000W Portable X-ray System. It confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements. It specifies the "Indications for Use" but does not include data from performance studies or acceptance criteria tables.

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