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510(k) Data Aggregation

    K Number
    K250863

    Validate with FDA (Live)

    Device Name
    FUJIFILM Ultrasonic Endoscope EB-710US
    Manufacturer
    FUJIFILM Corporation
    Date Cleared
    2025-12-12

    (266 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Age Range
    2 - 120
    Reference & Predicate Devices
    K220957,K121035,K183525
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is an ultrasonic endoscope intended for the observation, diagnosis and endoscopic treatment of the esophagus, trachea, bronchus and lesions adjacent to these structures using ultrasonic images, at medical facilities under the management of physicians.

    This product is not intended for use on children and infants.

    Device Description

    EB-710US (referred to as 'the device') is a medical ultrasonic electronic endoscope. The device is inserted into a lumen, a coelom, body cavity, or inside of a body, and provides images for observation, diagnosis, photographing, or treatment. It is also used for ultrasonography by visualizing the shape, the characteristic, or the dynamics of the inside of the body.

    This product is comprised of three general sections: an insertion portion, a control portion, and a connector portion to the peripherals. The insertion portion is flexible and contains glass fiber bundles, a channel, a complementary metal-oxide semiconductor (CMOS) image sensor and a ultrasonic transducer in its distal end. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion portion to illuminate the body cavity. This provides enough light to the CMOS image sensor to capture an image and display it on the monitor. The channel in the insertion portion assist in delivering suction as well as endoscopic accessories. The control portion controls the angulation of the bending portion in the insertion portion. The connector portion consists of electronic components needed to operate the endoscope when connected to the video processor.

    This product is used in combination with FUJIFILM's video processors, light sources, and peripheral devices such as monitor, printer, foot switch, and cart. And the device drives ultrasonic transducer installed in the distal end of the device by being connected with a ultrasonic processor.

    The driven ultrasonic transducer emits ultrasound into the body, and receives the reflected ultrasonic signal from the body. The ultrasonic processor connected to the device performs image processing using the received signal. The electric signal of the image processing is converted into video signal, and it is output to the monitor as a ultrasonic image.

    AI/ML Overview

    N/A

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