Caption Interpretation Automated Ejection Fraction Software is an AI-enabled medical device from Caption Health, Inc, listed by FDA (De Novo, DEN220063) with a decision date of 2023-02-24. Review panel: Radiology.
| FDA submission number | DEN220063 |
|---|---|
| Pathway | De Novo |
| Company | Caption Health, Inc |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-02-24 |
| Decision | Unknown |
| Product code | QVD |
| Classification | Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan |
| Device class | 2 |
| Regulation number | 892.2055 |
| Review time (calendar days) | 149 |
| Applicant country | US |
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.