Product code SFE

Device name

Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.1500

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.

Source

FDA openFDA device classification dataset