BrainInsight is an AI-enabled medical device from Hyperfine, Inc., listed by FDA (510(k), K223268) with a decision date of 2022-12-16. Review panel: Radiology.
| FDA submission number | K223268 |
|---|---|
| Pathway | 510(k) |
| Company | Hyperfine, Inc. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2022-12-16 |
| Decision | Substantially Equivalent |
| Product code | QIH |
| Classification | Automated Radiological Image Processing Software |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 53 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Hyperfine, Inc. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.