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a) EG-S100XT
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

b) VS-1000
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope.

A. Intended Use/Indications for Use

a) EG-S100XT
This product is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

b) VS-1000
This product is a non-sterile, reusable display device designed to display live image data from FUJIFILM single-use endoscope. For information on indications for use, refer to the operation manuals of compatible FUJIFILM single-use endoscopes.

B. Technological characteristics

a) EG-S100XT
This product is upper gastrointestinal endoscope, is inserted into a lumen, coelom, body cavity, or the inside of the body to provide these regions images for observation, diagnosis, and treatment. This product is inserted through the oral. The flexible tube (hereinafter "the insertion tube") follows the figure of the upper gastrointestinal tract performing a bending operation. The tip of the endoscope reaches to the duodenum. It is used for observation, diagnosis, and treatment of the esophagus, stomach, and duodenum.

Insertion portion of this product has a mechanism (hereinafter "the bending section") which bends the tip from right to left and up and down, and the insertion tube consists of the bending section and operating portion with a knob which controls the bending section. The instrument channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the endotherapy device. This product is a sterile, single-use device and not intended to be reprocessed.

b) VS-1000
This product has image processing, light source control, AE (shutter) control functions, a connector for endoscopes, and a connector for display units, and provides images for observation, diagnosis, photography, or treatment in body cavities by connecting the display unit and endoscope.

C. Principles of Operation

a) EG-S100XT
The Endoscope Model EG-S100XT function on the same principles of operation as the predicate device.

This product is lighted by LED at the tip. Its reflection forms an image on CMOS image sensor through a group of object lens placed and set in the tip of this product. An electric signal from CMOS image sensor is transmitted to the processor connected to this product. The processor converts it to a video signal and displays an image on a monitor.

It is possible to do endoscopic fulguration, which enable a user to apply high-frequency electric current to objective regions inserting a high-frequency endotherapy device into the instrument channel of the operating portion. Since there are no exposed metal parts (conductive parts) on the endoscope surface that can be contacted in use, the endoscope can safely perform procedures using high-frequency current.

b) VS-1000
The product controls the light source mounted on the endoscope, receives electrical signals output from the endoscope's image sensor and outputs them as video signals to the display unit after performing image processing such as colour and image quality correction and enhancement.

The display unit's operating console and the endoscope application software built into the display unit are used to manage patient information, adjust white balance, and provide images and patient information to network devices.

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