PEA · Class II · 21 CFR 876.1500

FDA Product Code PEA: Endoscope, Accessories, Image Post-processing For Color Enhancement

Alternative Mode Of Visualization Using Image Post-processing Algorithms Of The Received White Light Image For Color Enhancement.

Leading manufacturers include Pentax of America, Inc..

2
Total
2
Cleared
71d
Avg days
2023
Since

List of Endoscope, Accessories, Image Post-processing For Color Enhancement devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Jun 03, 2025
PENTAX Medical Video Processor (EPK-i8020c)
K251127
Pentax of America, Inc.
Gastroenterology & Urology · 53d
Cleared Jul 28, 2023
PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL
K231249
Pentax of America, Inc.
Gastroenterology & Urology · 88d

How to use this database

This page lists all FDA 510(k) submissions for Endoscope, Accessories, Image Post-processing For Color Enhancement devices (product code PEA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Gastroenterology & Urology FDA review panel. Browse all Gastroenterology & Urology devices →