HYPER AiR is an AI-enabled medical device from Shanghai United Imaging Healthcare Co.,Ltd., listed by FDA (510(k), K210001) with a decision date of 2021-04-30. Review panel: Radiology.
| FDA submission number | K210001 |
|---|---|
| Pathway | 510(k) |
| Company | Shanghai United Imaging Healthcare Co.,Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2021-04-30 |
| Decision | Substantially Equivalent |
| Product code | KPS |
| Classification | System, Tomography, Computed, Emission |
| Device class | 2 |
| Regulation number | 892.1200 |
| Review time (calendar days) | 116 |
| Applicant country | CN |
Official FDA database record · FDA AI-enabled device list
More devices from Shanghai United Imaging Healthcare Co.,Ltd. · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.