Cleared Traditional

K140149 - EPX-4440HD DIGITAL VIDEO PROCESSOR

K140149 is an FDA 510(k) clearance for EPX-4440HD DIGITAL VIDEO PROCESSOR, manufactured by Fujifilm Medical Systems U.S.A, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code PEA cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K140149 · Fujifilm Medical Systems U.S.A, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
212d
Days
Class 2
Risk

K140149 is an FDA 510(k) clearance for the EPX-4440HD DIGITAL VIDEO PROCESSOR. Classified as Endoscope, Accessories, Image Post-processing For Color Enhancement (product code PEA), Class II - Special Controls.

Submitted by Fujifilm Medical Systems U.S.A, Inc. (Wayne, US). The FDA issued a Cleared decision on August 22, 2014 after a review of 212 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujifilm Medical Systems U.S.A, Inc. devices

FDA 510(k) Submission Details - K140149

510(k) Number K140149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2014
Decision Date August 22, 2014
Days to Decision 212 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 131d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

PEA Device Classification - Class 2, Special Controls

Product Code PEA Endoscope, Accessories, Image Post-processing For Color Enhancement
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02005393 Completed Interventional Industry-sponsored

Study Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

A Concurrence Study of Diagnostic Visualization Comparing Flexible Spectral-Imaging Color Enhancement (FICE) With Olympus Narrow Band Imaging (NBI)

20
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Routine Endoscopy
Study design Single group
Eligibility All sexes · 21 Years+ · Healthy volunteers accepted
Principal investigator Mary Moore
Sponsor Fujifilm Medical Systems USA, Inc. (industry)
Started 2013-10-01 → Primary completion 2013-11-01
Primary outcome
Image Quality Scores Using Likert Scale
View full study on ClinicalTrials.gov

Regulatory Peers - PEA Endoscope, Accessories, Image Post-processing For Color Enhancement

All 8
Devices cleared under the same product code (PEA) and FDA review panel - the closest regulatory comparables to K140149.
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
K173679 · Pentax of America, Inc. · Jul 2018
Fuse Endoscopic System with FuseBox Processor
K160275 · Endochoice, Inc. · Aug 2016
PENTAX Medical EPK-i7010 Video Processor with GI Family
K150618 · Pentax of America, Inc. · Nov 2015
PENTAX EPK-I5010 VIDEO PROCESSOR
K122470 · Pentax Medical · Apr 2013