Introduction
The FUJIFILM Endoscope Model EC-760S-A/L is a medical device intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Device Description
The device consists of three general sections: a control portion, an insertion portion, and an umbilicus. The control portion controls the angulation of the endoscope, while the insertion portion contains glass fiber bundles, channels, and a CMOS image sensor. The umbilicus consists of electronic components needed to operate the endoscope.
Endoscopy Support Program EW1O-VMO1
This software provides image information to assist the user in estimating the size of an object displayed in the endoscopic field of view. It superimposes a virtual scale in the endoscopic image, allowing for accurate size estimation.
The device is classified as a Class II device under 21 CFR 876.1500 and is substantially equivalent to legally marketed predicate devices.
Manual:
Download: FUJIFILM Endoscope Model EC-760S-A/L with Endoscopy Support Program EW1O-VMO1 User Manual
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