4 devices · 1 company · 2021 to 2024
Shanghai United Imaging Intelligence Co., Ltd.: AI-enabled devices on FDA's list
4 devices from Shanghai United Imaging Intelligence Co., Ltd., 2021 to 2024, from 1 company across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (4 of 4 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Shanghai United Imaging Intelligence Co., Ltd.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| uAI Easy Triage ICHK242292 · 510(k) | Radiology | QAS | database entry | |
| uAI PortalK240411 · 510(k) | Radiology | QIH | database entry | |
| uMR 680K222755 · 510(k) | Radiology | LNH | database entry | |
| uAI EasyTriage-RibK193271 · 510(k) | Radiology | QFM | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.