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510(k) Data Aggregation

    K Number
    K140956
    Device Name
    LCD MONITOR
    Manufacturer
    NORDICNEUROLAB
    Date Cleared
    2014-08-07

    (115 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The LCD monitor is intended to be used by trained professionals as a fMRI viewing monitor within the MR environment.

    This device must not be used for a life support system. This device must not be used for diagnostics.

    Device Description

    The LCD Monitor is designed for the purpose of viewing images for MRI applications within the MR environment. The high resolution panels combined with high performance image processing controller, provides the users extremely high definition and high quality medical image displays. The monitor comply with international EMC and safety standards for medical devices.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the format you requested.

    The document is a 510(k) premarket notification for an "LCD Monitor" from Nordic NeuroLab AS. It discusses the regulatory classification, intended use, and substantial equivalence to a predicate device. It mentions compliance with safety and EMC standards and "performance testing" but does not detail:

    • Specific performance acceptance criteria (e.g., minimum brightness, contrast ratio, resolution accuracy with quantitative thresholds).
    • Reported device performance against those criteria.
    • Details about a study proving the device meets those criteria, such as sample size, data provenance, expert involvement, or ground truth establishment methods.
    • Information related to AI product development and validation, such as MRMC studies, standalone performance, training set details, or ground truth for training.

    The document primarily focuses on regulatory compliance for a medical device that is a specialized monitor, not an AI/ML-driven diagnostic or image processing device. The "Performance Testing" section states that the device meets design and performance specifications but does not provide details of how this was demonstrated or what those specifications quantitatively were.

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