De Novo DEN200055
- Device
- GI Genius
- Contact
- steven a. kradjian
- De Novo number
- DEN200055
- Product code
- QNP
- Regulation
- 876.1520
- Classification name
- gastrointesinal lesion software detection system
- Decision
- granted (DENG)
- Decision date
- 2021-04-09
- Date received
- 2020-09-08
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QNP
- Device name
- Gastrointesinal Lesion Software Detection System
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.1520
- Implant
- N
- Life sustain/support
- N