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510(k) Data Aggregation

    K Number
    K090603
    Device Name
    BARCO 5MP MAMMO, MODEL MDMG-5221
    Manufacturer
    BARCO NV
    Date Cleared
    2009-04-22

    (48 days)

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

    BARCO 5MP MAMMO, MODEL MDMG-5221

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

    The Barco 5MP Mammo device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review and analysis by trained medical practitioners.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but this document contains a letter from the FDA regarding a 510(k) premarket notification for a medical device (Barco 5MP Mammo), not a study report or clinical trial results. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria and performance data.

    The document states that the device is "intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review and analysis by trained medical practitioners." This indicates its intended use as a medical display, not an AI-powered diagnostic device.

    To answer your request, I would need a document detailing a clinical study or performance evaluation of a device, including its acceptance criteria and results.

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