# K243260: FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Apr 11, 2025 after 178 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). 51 ancestors in all.
1 later device descends from it; 1 cites it directly.
3 of 53 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 5.
- K172916: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603, Fujifilm Corporation (2018) Summary page 5.
- K240142: FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP, Fujifilm Corporation (2024) Summary page 5.

## Most influential descendants
- K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (2026), 0 descendants of its own

## Indications for use
a. Processor EP-8000 - 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. b. Endoscope Model EG-860R 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.

Source page: https://510kreport.com/device/K243260
Methodology: https://510kreport.com/methodology