De Novo DEN190040
- Device
- Caption Guidance
- Contact
- sam surette
- De Novo number
- DEN190040
- Product code
- QJU
- Regulation
- 892.2100
- Classification name
- image acquisition and/or optimization guided by artificial intelligence
- Decision
- granted (DENG)
- Decision date
- 2020-02-07
- Date received
- 2019-08-27
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- QJU
- Device name
- Image Acquisition And/Or Optimization Guided By Artificial Intelligence
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.2100
- Implant
- N
- Life sustain/support
- N