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510(k) Data Aggregation

    K Number
    K232028
    Device Name
    Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
    Date Cleared
    2023-11-17

    (133 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    IQ Endoscopes Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    IQ Endoscope's Gastroscope is intended to provide a live video stream in the upper gastrointestinal (GI) tract of adult patients to facilitate diagnosis of conditions in a clinical setting. The device channel which facilitates the capability to perform diagnostic/ therapeutic procedures of the upper GI tract. The device is sterile and single use and is not intended on being reprocessed. IQ Endoscope's Q Base Q-100 Base Unit is designed to be used with IQ Endoscope's Q Vision G-100 Gastroscope and other ancillary equipment (e.g. medical grade video monitor) for endoscopic surgery within the upper digestive tract. IQ Endoscope's Q Base Q-100 Unit is a reusable device intended to provide compressed air, power, and data connectivity to IQ Endoscope's Q Vision G-100 Gastroscope to facilitate diagnosis of conditions in a clinical setting.
    Device Description
    The G-100 Gastroscope is only intended on being used with the Q-100 Base Unit. A description of the two devices and their functions can be found below: IQ Endoscope's gastroscope is intended to provide a live video stream in the upper gastrointestinal (GI) tract of adult patients to facilitate diagnosis of conditions in a clinical setting. The device contains a working channel which facilitates the capability to perform diagnostic/ therapeutic procedures of the upper GI tract. The device is sterile and single use and is not intended on being reprocessed. The G-100 Gastroscope is a flexible trans-orally introduced gastroscope which can be used to examine the oesophagus, stomach and the first and second parts of the duodenum using a live video feed from the Q-100 Base Unit. The device contains a working channel which facilities the capability to perform diagnostic and therapeutic procedures where indicated. Additionally, the device features water, air and suction channels to provide water, insufflate with air, and removal of debris as required during the endoscopy procedure. A water jet also allows the clinician to clear the distal tip lens of debris to ensure continued visualisation of the gastrointestinal tract throughout the procedure. IQ Endoscope's Q Base Q-100 Base Unit is designed to be used with IQ Endoscope's Q Vision G-100 Gastroscope and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the upper digestive tract. IQ Endoscope's Q Base Q-100 Base Unit is a reusable device intended to provide compressed air, power, and data connectivity to IQ Endoscope's Q Vision G-100 Gastroscope to facilitate diagnosis of conditions in a clinical setting. The device connects air, power and data circuits to the G-100 gastroscope through a proprietary quick connector. The device connects to a 3rd party sterile water for irrigation and a visual display through an HDMI or BNC connection. The device may connect to a 3rd party data capture and storage accessory through an BNC connection for video and programmable on/off momentary button inputs.
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