# K150221: EPX-4440HD and EPX-4400HD with FICE

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Oct 1, 2015 after 244 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: 9 generations back to K931154 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
3 of 32 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The EPX-4400 and EPX-4400HD Digital Video Processors with FICE are used for endoscopic observation, diagnosis, treatment, and image recording. The devices are intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). The devices may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope, light source, monitor, recorder and various peripheral devices. FICE is an adjunctive tool for gastrointestinal endoscopic examination which can be used to supplement FUJIFILM white light endoscopy. FICE is not intended to replace histopathological sampling as a means of diagnosis.

Source page: https://510kreport.com/device/K150221
Methodology: https://510kreport.com/methodology