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The Flexible Video-Choledochoscope is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

Flexible Video-Choledochoscope is a kind of medical instrument, also known as optical camera, which can enter into the human biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. This device must be used with a duodenoscope. The product is equipped with tiny size digital imaging parts -- photoelective sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on its monitor output for doctor observation and diagnosis.

The Biliary Pancreaticobiliary Scope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope and the Image Processor. The Single-use Biliary Pancreaticobiliary Scope is intended to provide direct visualization, illumination and to guide accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Image Processor is intended to receive, process, and output images from the Single-use Biliary Pancreaticobiliary Scope for diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts.

The Biliary Pancreaticobiliary Scope System comprises two components: the Single-use Biliary Pancreaticobiliary Scope (model:CL-A, CL- B), and the Image Processor (model: HUV-02). The Single-use Biliary Pancreaticobiliary Scope is a flexible scope, introduced into the pancreatico-biliary system via a duodenoscope. The Single-use Biliary Pancreaticobiliary Scope comprises a handle, an insertion tube, and a connection cable.

The Dragonfly Pancreaticobiliary Scope is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Digital Controller is intended to provide illumination power and receive, process and output images from the Dragonfly Pancreaticobiliary Scope for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Instrument Channel Caps are used to cover the biopsy/suction channel inlet of an Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope used for singleoperator per-oral 2holoangiopancreatoscopy. The Dragonfly Pancreaticobiliary System is comprised of two components: The Dragonfly Pancreaticobiliary Scope and the Dragonfly Digital Controller. The Dragonfly Pancreaticobiliary Scope System is intended to provide direct visualization and to guide both optical and accessory devices for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The Dragonfly Pancreaticobiliary Scope is a single-use catheter which provides direct visualization with a camera and illumination, and enables access and delivery of accessories to targeted pancreaticobiliary anatomy. The Dragonfly Pancreaticobiliary Scope comprises of a handle, a catheter, imaging and illumination elements, and a video connection mechanism. The Dragonfly Digital Controller is a reusable accessory which controls illumination and receives, processes, and outputs video signals from the Dragonfly Pancreaticobiliary Scope. The system does not treat or diagnosis conditions. The Dragonfly Instrument Channel Caps, which are included in package with the Dragonfly Pancreaticobiliary Scope, are used to cover the opening to the biopsy/suction channel inlet of a Olympus®, Fujifilm® or Pentax® duodenoscope. The Instrument Channel Caps are intended for exclusive use with the Dragonfly Pancreaticobiliary Scope to provide access for passage, while maintaining insufflation and minimizing leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.

Choledochoscope System is intended to be used by physicians through percutaneous insertion to access, visualize, and perform procedures in the pancreaticobiliary system including the hepatic ducts and the common bile duct. The image processor provides illumination for the choledochoscope, and is also used to receive the signal from the endoscope, convert it into an image and display it on the examination monitor. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.

The Choledochoscope System consists of a single-use choledochoscope to provide illumination and intuitive images in endoscopic surgery of the pancreatic ductal system and serves as a guide to diagnosis and management with accessories and an image processor for clinical image processing. The single-use choledochoscope is a sterile single-use flexible choledochoscope and has the following 4 models: CH-M50, CH-M52, CH-M40, CH-M32. The four models are the same except for the difference in the characteristics of the insertion tube, including diameter of the insertion tube, maximum insertion portion width and minimum insertion channel width. The image processor is a reusable monitor. The single-use choledochoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The image processor processes the images from the choledochoscope and outputs video signals to a display.

AnQing Medical Flexible Choledochoscope has been designed to be used with the video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopic diagnosis and treatment within the bile duct. The Flexible Choledochoscope is designed for use in adults.

The Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) is a sterile single-use endoscope which is used with the video processor (Model: EOS-H-01. FDA cleared #K211169) produced by AnQing for providing endoscopic imaging within the bile duct for the purpose of diagnosis and treatment. The 2 proposed models are identical except the deflection versions, which is opposite from each other (EU version or US version). The Flexible Choledochoscope is a single-use endoscope, which consists of Handle, Insertion Section, Distal Tip, and Endoscope Connector. The handle includes a deflection lever, a lever lock, an aspiration button, an aspiration connector, a push button for picture taking/video recording and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion contains one working channel and wiring to transmit the image signals to the Video Processor. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, LEDs for illumination, and the distal opening of the working channel. The endoscope connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.

The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. The Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment.

The Pusen Single Use Flexible Video Cystoscope/Choledochoscope System includes a Single Use Flexible Video Cystoscope/Choledochoscope and an HD Medical Video Endoscope Image Processor. This system is intended to be used for endoscopic access to and examination of the lower urinary tract. This system is also indicated for the examination and therapeutic applications during endoscopic procedures in bile ducts. This Cystoscope/Choledochoscope is intended to provide visualization via video processor and can be used with endoscopic accessories. This system is intended for use in a hospital environment or medical office environment. - The Pusen Single Use Flexible Video Cystoscope/Choledochoscope is provided sterile and has the following 4 models: PC200-AS, PC200-AR, PC200-S, and PC200-R. - The Pusen Single Use Flexible Video Cystoscope/Choledochoscope needs to be connected with the HD Medical Video Endoscope Image Processor PV300 as a system, and it is powered by the latter. - The HD Medical Video Endoscope Image Processor PV300 is a reusable device, used to process the image signal from the Pusen Single Use Flexible Video Cystoscope/Choledochoscope and display the real-time video on its LCD screen, which enables visual examination of target site.

The Flexible Video-Choledochoscope System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The Flexible Video-Choledochoscope System comprises two components: the Flexible Video- Choledochoscope and Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is indicated for use in diagnostic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The imaging processor system (including the light source) provides illumination for Flexible Video-Choledochoscope and is also used to receive the signal from the endoscope, then convert it into an image and display it on the examination monitor.

Flexible Video-Choledochoscope System is composed of sterile Flexible Video-Choledochoscope and a non-sterile Imaging Processor System (Including Light Source). The Flexible Video-Choledochoscope is composed of Operation section, Light-guide Section, Insertion a Distal tip and bending section. The Operation Section is pulled by the wire rope to control the bending direction of the Distal tip. The Light-guide section transmits the illumination light from the image processor to the Distal tip. The Insertion Tube is used to guide it into other instruments or cavity of the body. The Distal tip contains a camera system and a lighting system for illumination and observation. Imaging Processor System (Including Light Source) is composed of lighting system, image processing board. The lighting system provides the light source for the endoscope probe at the back end. The image processing board receives electronic signals from the front-end camera module and processes them, and finally transmits them to the display through the video interface. Flexible Video-Choledochoscope is a kind of medical electronic optical instrument, also known as optical camera, which can enter into the human biliary and pancreatic duct for observation and diagnosis. The operator delivers the optical camera system to the site of diagnosis and treatment by means of a mechanical part with a flexible insertion tube and a system of bends. The product is equipped with tiny size digital imaging parts --photoelectric sensors "CMOS", on which the objects in human cavity will be transferred though lens optical system, and converts light signals into electrical signals. The electrical signal will be transferred to Imaging Processor System (Including Light Source) and display images on its monitor output for doctor observation and diagnosis.

The Pancreaticobiliary Video System consists of PB Digital Controller and Single-use Video Pancreaticobiliary Scope. The Single-use Video Pancreaticobiliary Scope is used in combination with the PB digital controller, which is designed to provide imaging for the diagnosis and treatment application of endoscopic surgery process of pancreatic biliary system, and provide working channel for other diagnosis and treatment accessories. The PB Digital Controller can be used together with the Single-use Video Pancreaticobiliary Scope of Micro-Tech to process the image collected by the scope and transmit it to the display.

Pancreaticobiliary Video System consists of: Single-Use Video Pancreaticobiliary Scope: - CDS11001 - CDS11002 - CDS11003 - CDS11004 - CDS11005 - CDS22001 ● - CDS22002 - CDS22003 - CDS22004 - CDS22005 PB Digital Controller: - BS-W-100 The Single-Use Video Pancreaticobiliary Scope is a sterile single use flexible scope and PB Digital Controller is a reusable device. The Single-Use Video Pancreaticobiliary Scope has the following physical and performance characteristics: - Maneuverable tip controlled by the user - Insertion port - Suction port - Camera at the distal tip and LED light source in the handle of the pancreaticobiliary scope The light emitted by the cold light source located in the handle is transmitted to the distal end of the pancreaticobiliary scope through the glass fiber, and irradiates the human tissue from the distal end. CMOS and glass fiber are located at the same position at the distal end. CMOS transmits the collected image information to the PB Digital Controller through cable, and the PB Digital Controller displays the image on the display after processing. CMOS and optical components are identical for all specifications of products. - Working channel port - Lever which can lock the control The Single-Use Video Pancreaticobiliary Scope have different size as follows: - Maximum insertion portion width - Effective working length - Minimum accessories channel width The PB Digital Controller has the following physical and performance characteristics: - Displays the image from The Single-Use Video Pancreaticobiliary Scope on the screen - Can record screenshots or video of image from the Single-Use Video Pancreaticobiliary Scope - Can connect to an external monitor - Reusable device

The SpyGlass Discover Digital System is indicated for use in diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts. The SpyGlass Discover Digital System comprises two components: the SpyGlass Discover Digital Catheter and the SpyGlass Discover Digital Controller. The SpyGlass Discover 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 SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic Controller: The SpyGlass Discover Digital Controller is intended to provide illumination and receive, process, and output images from the SpyGlass Discover Digital Catheter for diagnostic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The SpyGlass Discover Digital System comprises two components: (1) a sterile, single-use endoscope, the SpyGlass Discover Digital Catheter (the "Catheter"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass Discover Digital Controller (the "Controller"). The SpyGlass Discover Digital Catheter comprises a handle, an insertion tube, and a connection cable. The handle includes two articulation control knobs, a lever to lock the control knobs in place, connectors for irrigation and aspiration, a working channel port. The insertion tube contains one working channel for accessory devices and aspiration, two channels for irrigation, two optical fibers to transmit illumination from the Controller, and wiring to transmit video signals to the Controller. The bending section at the distal portion of the insertion tube is controlled by the user via the articulation control knobs on the handle. The distal end of the insertion tube contains a camera for capturing video and transmitting it to the Controller, elements for transmitting illumination from the Controller, and the distal openings of the irrigation and working channels. The catheter cable connects the catheter handle to the Controller for transmitting illumination and video signals. The Controller is an endoscopic video imaging component that combines the functionality of a camera and an LED light source. The Controller receives video signals from the catheter, processes the video signals, and outputs video images to an attached monitor. The Controller also generates and controls the illumination transmitted to the distal end of the catheter. The user interface of the Controller comprises a power button, a receptacle to connect the catheter connection cable, buttons to turn illumination on or off and to control the illumination intensity, and an illumination intensity indicator. The Controller outputs video images to an attached monitor via DVI, VGA, or S-Video ports, and the user may select NTSC or PAL video formats according to the geographic region of use.

The SpyGlass DS and DS II Direct Visualization System is indicated for use in diagnostic and therapeutic applications during endoscopic procedures in the pancreatico-biliary system including the hepatic ducts. The SpyGlass DS and DS II Direct Visualization System comprises two components: the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter, and the SpyGlass DS Digital Controller. The SpyScope DS Access and Delivery Catheter and SpyScope DS II Access and Delivery Catheter are 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 SpyGlass DS Digital Controller is intended to provide illumination and receive, process, and output images from the SpyScope DS Access and Delivery Catheter or SpyScope DS II Access and Delivery Catheter for diagnostic and therapeutic applications during endoscopic procedures in the pancreaticobiliary system including the hepatic ducts.

The SpyGlass DS and DS II Direct Visualization System comprises two components: (1) a sterile, single-use choledochoscope, either the SpyScope DS Access and Delivery Catheter or the SpyScope DS II Access and Delivery Catheter (the "Scope"); and (2) a non-sterile endoscopic video imaging system, the SpyGlass DS Digital Controller (the "Controller"). The Scope is introduced into the pancreatico-biliary system via a duodenoscope. The Scope comprises a handle, an insertion tube, and a connection cable. The handle includes two articulation control knobs, a lever to lock the control knobs in place, connectors for irrigation and aspiration, a working channel port, and a strap to attach the Scope to the duodenoscope. The insertion tube contains one working channel for accessory devices and aspiration, two channels for irrigation, two optical fibers to transmit illumination from the Controller, and wiring to transmit video signals to the Controller. The bending section at the distal portion of the insertion tube is controlled by the user via the articulation control knobs on the handle. The distal end of the insertion tube contains a camera for capturing video and transmitting it to the Controller, elements for transmitting illumination from the Controller, and the distal openings of the irrigation and working channels. The connection cable connects the Catheter handle to the Controller for transmitting illumination and video signals. The Controller is an endoscopic video imaging component that combines the functionality of a camera and an LED light source. The Controller receives video signals from the Scope, processes the video signals, and outputs video images to an attached monitor. The Controller also generates and controls the illumination transmitted to the distal end of the Scope. The user interface of the Controller comprises a power button, a receptacle to connect the Scope connection cable, buttons to turn illumination on or off and to control the illumination intensity, and an illumination intensity indicator. The Controller outputs video images to an attached monitor via DVI, VGA, or S-Video ports, and the user may select NTSC or PAL video formats according to the geographic region of use.