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510(k) Data Aggregation

    K Number
    K133994
    Device Name
    SIVR56-T KIT
    Manufacturer
    BARCO N.V.
    Date Cleared
    2014-12-01

    (340 days)

    Product Code
    DXJ
    Regulation Number
    870.2450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SIVR56-T KIT

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

    The SIVR56-T KIT is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted for the SIVR56-T KIT.

    The document is an FDA 510(k) clearance letter for the SIVR56-T Kit, classifying it as substantially equivalent to a predicate device. It specifies the regulation number (21 CFR 870.2450) and regulatory class (Class II) for a medical cathode-ray tube display. It also includes the "Indications for Use" statement, which describes the device's purpose: "The SIVR56-T KIT is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display."

    The document discusses regulatory compliance, labeling, and reporting requirements, but does not contain any data, studies, or acceptance criteria related to the device's performance.

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