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    K Number
    K143232
    Device Name
    Universal Digital Interface 2W, UDI 2W
    Manufacturer
    MERIDIAN MEDICAL SYSTEMS, LLC
    Date Cleared
    2015-01-30

    (81 days)

    Product Code
    MQB
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Universal Digital Interface 2W, UDI 2W

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

    The UDI 2W system is a direct digital radiographic upgrade unit used to directly capture and convert conventinal projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, it can be printed and/or stored electronically. The Meridian UDI 2W unit provides digital radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The UDI 2W system can be used with a fixed, portable, or wireless 17"X17" or 14"x17" sensor plate. The UDI 2W can not be used for Mammography applications.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Universal Digital Interface 2W (UDI2W) and primarily discusses its regulatory classification, indications for use, and compliance requirements. It does not include details on specific performance metrics, study designs, sample sizes, or expert qualifications.

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