Product code PEA

Device name

Endoscope, Accessories, Image Post-Processing For Color Enhancement

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1500

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

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

Source

FDA openFDA device classification dataset