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