HALO is an AI-enabled medical device from NICo-Lab B.V., listed by FDA (510(k), K200873) with a decision date of 2020-11-20. Review panel: Radiology.
| FDA submission number | K200873 |
|---|---|
| Pathway | 510(k) |
| Company | NICo-Lab B.V. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2020-11-20 |
| Decision | Substantially Equivalent |
| Product code | QAS |
| Classification | Radiological Computer-Assisted Triage And Notification Software |
| Device class | 2 |
| Regulation number | 892.2080 |
| Review time (calendar days) | 233 |
| Applicant country | NL |
Official FDA database record · FDA AI-enabled device list
More devices from NICo-Lab B.V. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.