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510(k) Data Aggregation

    K Number
    K981958
    Device Name
    LEISEGANG VIDEO COLPOSCOPE
    Manufacturer
    NETOPTIX CORP.
    Date Cleared
    1998-10-19

    (137 days)

    Product Code
    HEX
    Regulation Number
    884.1630
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K940094,K955635
    Why did this record match?
    Reference Devices :

    K940094, K955635

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

    The Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

    Device Description

    The Galileo Leisegang Video Colposcope is intended for magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image can be viewed only on a color monitor.

    The Leisegang Video Colposcope consists of a CCD camera with a halogen light source, green filter and is mounted on a mobile base.

    AI/ML Overview

    This 510(k) summary (K981958) is for the Leisegang Video Colposcope. It describes the device's intended use and compares it to predicate devices. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

    Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than performance data. The device is a direct viewing instrument, not an AI/algorithm-driven device, which means the requested parameters (e.g., sample size for training set, MRMC studies, ground truth) are not applicable to the information provided in this 510(k) summary.

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