# K140149: Epx-4440HD Digital Video Processor

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Aug 22, 2014 after 212 days
- Product code: PEA (Endoscope, Accessories, Image Post-Processing For Color Enhancement)
- 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: 8 generations back to K931154 (1993). 30 ancestors in all.
16 later devices descend from it; 4 cite it directly.
3 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102466: Fujinon Epx-4440HD Digital Video Processor, Fujinon, Inc. (2011) Summary page 5.
- K100584: Evis Exeraii 180 System, Olympus Medical Systems Corporation (2010) Summary page 5.

## Most influential descendants
- K163675: Processor VP-7000, Light Source BL-7000 (2017), 12 descendants of its own
- K162836: FUJIFILM Surgical System (2017), 8 descendants of its own
- K192918: Video Laparoscope, Video Processor, Light Source (2020), 6 descendants of its own
- K203717: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 (2021), 3 descendants of its own
- K250268: HyperSnap Surgical System (HSS) (2025), 1 descendant of its own

## Indications for use
The VP-4440HD unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product 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/K140149
Methodology: https://510kreport.com/methodology