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

FDA product code SFE · 2 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1500
Review panel
SU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-06-24 – 2026-06-04

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

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