Caption Guidance is an AI-enabled medical device from Bay Labs, Inc., listed by FDA (De Novo, DEN190040) with a decision date of 2020-02-07. Review panel: Radiology.
| FDA submission number | DEN190040 |
|---|---|
| Pathway | De Novo |
| Company | Bay Labs, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2020-02-07 |
| Decision | Unknown |
| Product code | QJU |
| Classification | Image Acquisition And/Or Optimization Guided By Artificial Intelligence |
| Device class | 2 |
| Regulation number | 892.2100 |
| Review time (calendar days) | 164 |
| 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.