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510(k) Data Aggregation

    K Number
    K081109
    Device Name
    CORONIS 5MP MAMMO SL, MODEL MDMG 6121
    Manufacturer
    BARCOVIEW, MEDICAL IMAGING SYSTEMS
    Date Cleared
    2008-05-02

    (14 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CORONIS 5MP MAMMO SL, MODEL MDMG 6121

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

    The Coronis 5MP Mammo SL (MDMG 6121) Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) clearance letter for the Barco Coronis 5MP Mammo SL states that the device is intended for displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. However, the provided document does not contain information about the acceptance criteria or a study proving the device meets those criteria.

    The letter is a regulatory filing indicating substantial equivalence to a predicate device, which means it met the administrative requirements for marketing. It does not include performance data, study design, or any of the detailed information requested in the prompt regarding acceptance criteria and performance studies.

    Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment based on the provided text.

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