Skip to contentDe Novo DEN230023
- Device
- Rho
- Contact
- dr. catriona syme
- De Novo number
- DEN230023
- Product code
- SAO
- Regulation
- 892.1171
- Classification name
- radiology software for opportunistic evaluation of low bone mineral density
- Decision
- granted (DENG)
- Decision date
- 2024-04-09
- Date received
- 2023-04-03
- Classification advisory
- Radiology
- Review advisory
- Radiology
- Type
- Direct
Current FDA Classification#
- Product code
- SAO
- Device name
- Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
- Medical specialty
- Radiology
- Device class
- 2
- Regulation
- 892.1171
- Implant
- N
- Life sustain/support
- N