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This instrument has been designed to be used with the Olympus Video System Center, Light Source, Documentation Equipment, Video Monitor, Electrosurgical Unit, Endo-therapy accessories such as a Biopsy Forceps and other ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, and sigmoid colon, colon, and ileocecal valve).

The subject devices, EVIS EXERA Colonovideoscope XCF-Q160W1L/I are identical to the predicate device, CF-Q160AL/I, in intended use. These instrument have been designed to be used with an Olympus video system center, light source, documentation equipment, video monitor, endo-therapy accessories such as biopsy forceps and ancillary equipment for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). As for the device specifications, they are basically identical to the predicate devices, the CF-Q160AL/I, with the exception that the subject devices have wider field of views compared to the CF-Q160AL/I/. With this field of view, the XCF-Q160W1L/I may improve the detection of lesions in the colon and has been shown to reduce overall procedure time.