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510(k) Data Aggregation

    K Number
    K033153
    Device Name
    DICOM THEATER
    Manufacturer
    FERGUSON MEDICAL
    Date Cleared
    2004-04-23

    (206 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K023340
    Predicate For
    K042942
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DICOM Theater device is Intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

    Device Description

    The DICOM Theater device is a digital image display system. The DICOM Theater consists of components to provide high resolution visualization of digital images.

    AI/ML Overview

    The provided text is a 510(k) summary for the Barco NV DICOM Theater device, a digital image display system. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device (Coronis 1MP Medical Flat Panel Display System, K023340).

    The document does not contain information regarding specific acceptance criteria, a study that proves the device meets those criteria, or details regarding ground truth establishment, sample sizes, or expert qualifications for a performance study. It merely states the device's intended use and technological characteristics.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided. The document outlines the regulatory process and approval of the device, but not the technical performance study details that would be required to answer your questions.

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