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510(k) Data Aggregation

    K Number
    K251859
    Device Name
    EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
    Manufacturer
    Olympus Medical Systems Corporation
    Date Cleared
    2025-10-03

    (108 days)

    Product Code
    ODG
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K112680,K051541
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.

    The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    Device Description

    The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has been designed to be used with diagnostic ultrasound system, video system center, light source, documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.

    The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    AI/ML Overview

    N/A

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