FUJIFILM

Primary DI

04547410513790

Brand

FUJIFILM

Company

FUJIFILM CORPORATION

Model

EP-8000

Device description

- The EP-8000 is an endoscopic processor with an integrated light source that is intended to provide illumination, process electronic signals transmitted from a video endoscope and enable image recording.- This product can be used in combination with compatible medical endoscope, a monitor, a recorder and various peripherals.- It supplies air through the endoscope, for obtaining clear visualization and is used for endoscopic observation, diagnosis and treatment.- BLI (Blue Light Imaging), LCI (Linked Color Imaging), ACI (Amber-red Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examinations which can be used to supplement Fujifilm white light endoscopy.BLI, LCI, ACI and FICE are not intended to replace histopathological sampling as a means of diagnosis.- BLI, LCI, ACI and FICE are not intended for bronchoscopic examination.

Published

2025-05-31

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true