Rho is an AI-enabled medical device from 16 Bit Inc, listed by FDA (De Novo, DEN230023) with a decision date of 2024-04-09. Review panel: Radiology.
| FDA submission number | DEN230023 |
|---|---|
| Pathway | De Novo |
| Company | 16 Bit Inc |
| Review panel (specialty) | Radiology |
| FDA decision date | 2024-04-09 |
| Decision | Unknown |
| Product code | SAO |
| Classification | Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density |
| Device class | 2 |
| Regulation number | 892.1171 |
| Review time (calendar days) | 372 |
| Applicant country | CA |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.