SFE

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

Product code

SFE

Device name

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

Device class

Class 2

21 CFR

21 CFR 876.1500

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

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

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

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-06-04.

2 summaries are archived here for direct download.