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..
FDA 510(k) Cleared Endoscope, Accessories, Image Post-processing For Color Enhancement Devices (Product Code PEA)
About Product Code PEA - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code PEA since 2013, with 9 receiving FDA clearance (average review time: 188 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under PEA have taken an average of 53 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.
PEA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →