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The Tangent Single-Use Digital System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Tangent Single-Use Digital System comprises two components: the Tangent Single-Use Digital Catheter and the Tangent Digital Controller.

The Tangent Single-Use Digital Catheter is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Tangent Digital Controller is intended to provide illumination and receive, process, and output images from the Tangent Single-Use Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Tangent Single-Use Digital System, consisting of the Tangent Single-Use Digital Catheter and Tangent Digital Controller, is used in diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The Tangent Single-Use Digital Catheter is a single-use sterile imaging catheter that enables access and delivery of accessories to targeted portions of the pancreaticobiliary anatomy and displays live video when connected to the Tangent Digital Controller. It includes an articulation control knob, an articulation thumb lever, a locking thumb lever, an irrigation port with Luer fitting, aspiration port with control valve, working channel for accessories and irrigation/aspiration, LEDs to illuminate the image and wiring to transmit video and image signals to the Tangent Digital Controller.

The Tangent Digital Controller is an endoscopic viewing imaging controller that is required for use of the Tangent Single-Use Digital System. The Tangent Digital Controller provides the electronics to control camera function and LEDs at the catheter tip. The Tangent Digital Controller receives video signals from the Tangent Digital Catheter, processes the video signals, and outputs video images to a video monitor. Images and/or videos may be exported. The Tangent Digital Controller provides direct visualization of the pancreaticobiliary duct anatomy and enables exploratory and endotherapy procedures.

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