Cleared Traditional

K140149 - EPX-4440HD DIGITAL VIDEO PROCESSOR

K140149 is the FDA 510(k) clearance for EPX-4440HD DIGITAL VIDEO PROCESSOR by Fujifilm Medical Systems U.S.A, Inc.. It is a Class 2 Gastroenterology & Urology device (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

Submission Details

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
82d slower than avg
Panel avg: 130d · This submission: 212d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Devices cleared under the same product code (PEA) and FDA review panel - the closest regulatory comparables to K140149.
PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family
K191282 · Pentax of America, Inc. · Nov 2019
PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes
K173679 · Pentax of America, Inc. · Jul 2018
PENTAX Medical EPK-i7010 Video Processor with GI Family
K150618 · Pentax of America, Inc. · Nov 2015