De Novo DEN230027
- Device
- NaviCam ProScan
- Contact
- feng wang
- De Novo number
- DEN230027
- Product code
- QZF
- Regulation
- 876.1540
- Classification name
- gastrointestinal capsule endoscopy analysis software device
- Decision
- granted (DENG)
- Decision date
- 2023-12-12
- Date received
- 2023-04-14
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QZF
- Device name
- Gastrointestinal Capsule Endoscopy Analysis Software Device
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.1540
- Implant
- N
- Life sustain/support
- N