Red Dot is an AI-enabled medical device from Behold.AI Technologies Limited, listed by FDA (510(k), K191556) with a decision date of 2020-02-28. Review panel: Radiology.
| FDA submission number | K191556 |
|---|---|
| Pathway | 510(k) |
| Company | Behold.AI Technologies Limited |
| Review panel (specialty) | Radiology |
| FDA decision date | 2020-02-28 |
| Decision | Substantially Equivalent |
| Product code | QFM |
| Classification | Radiological Computer-Assisted Prioritization Software For Lesions |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 261 |
| Applicant country | GB |
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.