HALO is an AI-enabled medical device from Nico.Lab B.V., listed by FDA (510(k), K211788) with a decision date of 2021-07-08. Review panel: Radiology.
| FDA submission number | K211788 |
|---|---|
| Pathway | 510(k) |
| Company | Nico.Lab B.V. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-07-08 |
| 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) | 29 |
| 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.