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FUJIFILM Endoscope Model EC-760S-A/L This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. Never use this product for any other purposes. Endoscopy Support Program EW10-VM01 This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. This software provides no therapeutic or diagnostic function.

FUJIFILM Endoscope Model EC-760S-A/L is comprised of three general sections; a control portion, an insertion portion and an umbilicus. The control portion controls the angulation of the endoscope. This portion also controls the flexibility of the distal end in the endoscope. The insertion portion contains glass fiber bundles, several channels and a complementary metal-oxide-semiconductor (CMOS) image sensor, and laser emitting window in its distal end. The insertion portion assist in delivering air/suction as well as endoscope accessories. such as forceps. The glass fiber bundles allow light to travel through the endoscope and emit light from the tip of the insertion 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 umbilicus consists of electronic components needed to operate the endoscope when plugged in to the video processor and the light source. The endoscope is used in combination with the Company's video processors, light sources and peripheral devices such as monitor, printer, foot switch, and cart. Endoscopy Support Program EW10-VM01 is a software-only device that detects the laser spot position of the dedicated endoscope in the image obtained via the video processor and displays a superimposed scale ("Virtual Scale") in the endoscopic image (e.g., displayed in a monitor). The Virtual Scale images can be either linear or circular. The virtual scale shows the graduated markings at 5mm, 10mm, and 20mm. EW10-VM01 must be installed on a personal computer (PC) that meets the mandatory system requirements for it to function. When the PC with EW10-VM01 connects to the video processor and the Virtual Scale function is turned ON. EW10-VM01 automatically retrieves the calibration data from the EC-760S-A/L. EW10-VM01 uses the data from the calibration table and detects the relative position of the red laser beam in the endoscopic image. EW10-VM01 superimposes the virtual scale images in the endoscopic image in real-time. The virtual scale acts as the virtual reference for the users to estimate sizes.

The AccuMeasure™ System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure™ System provides no therapeutic or diagnostic function.

The device is used in conjunction with an endoscope to measure objects on the mucosal surface of the gastrointestinal (GI) tract. The device consists of two components (1) the measuring device and (2) a processing unit. The measuring device consists of a through the scope probe that is connected to a handheld laser source. The processing unit includes a video grabber and a touch screen PC. The medical-grade PC comes with dedicated software for conducting measurements during an endoscopic procedure.

The Dornier MINNOW Ureteral catheter is indicated for access and catheterization of the urinary tract, including the following applications: Delivery of contrast media Drainage of fluids from the urinary tract Delivery of irrigation fluids to the urinary tract Navigation of a tortuous ureter Access, advancement, or exchange of wire quides The target population is for adults only (at least 22 years old).

The MINNOW Ureteral Catheter is a sterile single lumen medical grade thermoplastic elastomer (Pebax®) catheter. It is designed to assist in access to the upper urinary tract using standard endoscopic technique for drainage and delivery of gels or fluids. The device is offered without side holes and is available in 5 and 6 Fr. Sizes, which are common to the industry. The catheter is indicated for use by physicians for facilitating access to the urinary tract through a retrograde route and may be used in conjunction with a quidewire or for the injection of gels or fluids into the urinary tract. The catheter tip is radiused and has a .041" ID that allows for a smooth transition and passage when placed over a guidewire of up to 0.038" inches in diameter that is pre-positioned through the urological tract. The MINNOW Ureteral Catheters are packaged with a standard Touhy-Borst adapter that allows for injection or aspiration of fluids, but removable to allow for scope exchange without having to remove the catheter. The MINNOW Ureteral Catheters are available in 5 and 6 French (Fr) diameter, with a catheter length of 70 centimeters (cm).