# K180414: EPX-4440FN Digital Video Processor with Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm New Development U.S.A., Inc.
- Decided: May 24, 2018 after 98 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: 10 generations back to K931154 (1993). 33 ancestors in all.
No later device cites it as a predicate yet.
3 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162836: FUJIFILM Surgical System, Fujifilm New Development U.S.A., Inc. (2017) Summary page 4.
- K140149: Epx-4440HD Digital Video Processor, Fujifilm Medical Systems U.S.A, Inc. (2014) Summary page 4.

## Indications for use
The EPX-4440FN Digital Video Processor with Light Source is used for endoscopic or laparoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope or laparoscope (a video camera in an endoscope or laparoscope). This product may be used on all patients requiring endoscopic examination or laparoscopic surgical procedures and when using a FUJIFILM medical endoscope or laparoscope, light source, monitor, recorder and various peripheral devise. FICE (Flexible spectral-Imaging Color Enhancement) is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathologic sampling as a means of diagnosis.

Source page: https://510kreport.com/device/K180414
Methodology: https://510kreport.com/methodology