# K192286: FUJIFILM EP-6000 Video Processor

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: May 1, 2020 after 253 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931154 (1993). 35 ancestors in all.
No later device cites it as a predicate yet.
3 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163675: Processor VP-7000, Light Source BL-7000, Fujifilm Medical System U.S.A., Inc. (2017) Summary page 4.

## Indications for use
The EP-6000 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) 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 and FICE are not intended to replace histopathological sampling as a means of diagnosis. BLI, LCI, and FICE are not intended for bronchoscopic examination.

Source page: https://510kreport.com/device/K192286
Methodology: https://510kreport.com/methodology