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510(k) Data Aggregation

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

    This Single-use Video Cholangioscope is intended to use in conjunction with endoscopic image processor to provide images for diagnostic and therapeutic applications in the pancreatico-biliary system and to provide a working channel for other endoscopic accessories.

    This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

    Device Description

    The subject device, Cholangioscope Visualization System, comprises two components: the Single-use Video Cholangioscope and the Full HD Visualization Endoscopic Image Processor.

    The Single-use Video Cholangioscope is a single use sterile device. It is composed of working channel, control wheel, operation section, insertion section (integrated with a video image sensor and lighting components), plug section, connection cable, water supply channel, suction channel and accessory- irrigation valve.

    The operation section allows users to connect and operate the product. It includes two control wheels (large/small control wheel) to control the bending section at the insertion section to bend in four directions, a lock mechanism can be rotated clockwise to lock the control wheel in its current position, a working channel port can be used for inserting accessories and suction, a bundle mechanism is used to fix the Single-use Video Cholangioscope to the duodenoscope, a water supply port for connecting to the water supply tube, a suction port for connecting to suction tube with a flow control value, and a plug section for connecting with the image processor.

    The insertion section can be inserted in patient entirely, and it includes a bending section and a distal end. The bending section can be bent >=50 degrees in four directions by the control wheel. The distal end includes a miniature Complementary Metal Oxide Semiconductor (CMOS) camera, two light-emitting diode (LED) illumination module, two water supply channels for inserting accessories and one working channel for discharging liquid to the suction tube.

    The accessory-irrigation value can be connected to the working channel port to expand the working channel, and provide an injection-suction dual-purpose port that can be used for liquid supply or suction through the working channel.

    This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images within the field of view from the body cavity on its LCD display and/or external monitor. The Full HD Visualization Endoscopic Image Processor has four models, they have the same hardware and the difference is mainly in the image adjustment functions.

    AI/ML Overview

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