uOmnispace is an AI-enabled medical device from Shanghai United Imaging Healthcare Co., Ltd, listed by FDA (510(k), K230039) with a decision date of 2023-07-20. Review panel: Radiology.
| FDA submission number | K230039 |
|---|---|
| Pathway | 510(k) |
| Company | Shanghai United Imaging Healthcare Co., Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2023-07-20 |
| Decision | Substantially Equivalent |
| Product code | QIH |
| Classification | Automated Radiological Image Processing Software |
| Device class | 2 |
| Regulation number | 892.2050 |
| Review time (calendar days) | 195 |
| 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.