PEA

Endoscope, Accessories, Image Post-Processing For Color Enhancement

Product code
PEA
Device name
Endoscope, Accessories, Image Post-Processing For Color Enhancement
Device class
Class 2
21 CFR
21 CFR 876.1500
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
9 (all years; only the last 3 years are listed here)

FDA classification definition

Alternative mode of visualization using image post-processing algorithms of the received white light image for color enhancement.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-06-03.

NumberDecision dateApplicantDevice nameSummary
K2511272025-06-03Pentax of America, Inc.PENTAX Medical Video Processor (EPK-i8020c)PDF

1 summaries are archived here for direct download.

Official FDA classification page: PEA
Classification and pathway per current FDA publications. Data from openFDA (CC0).