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510(k) Data Aggregation

    K Number
    K040399
    Device Name
    QONTRAST
    Manufacturer
    AMID
    Date Cleared
    2004-03-29

    (41 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K021966
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Qontrast software is a Windows 2000/Windows XP software application package. It is designed to view and quantify echographic image data.

    Device Description

    Qontrast software is a Windows 2000/Windows XP software application package. It is designed to view and quantify echographic image data.

    AI/ML Overview

    The provided 510(k) summary for the Qontrast software (K040399) does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria.

    The document is a standard 510(k) summary and FDA clearance letter, which typically focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It includes:

    • Submitter information: Contact details of the company and contact person.
    • Device identification: Trade name, common name, classification, and product code.
    • Predicate device: Information about the device Qontrast software is being compared to.
    • FDA clearance letter: Official communication from the FDA granting clearance to market the device.
    • Indications for Use: A brief description of the intended purpose of the device.

    Therefore, I cannot provide the requested information as it is not present in the given text.

    To answer your request, a different type of document, such as a validation report, performance study, or a more detailed technical submission, would be required.

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