The following data is part of a premarket notification filed by Shanghai United Imaging Intelligence Co., Ltd. with the FDA for Uai Easytriage-rib.
| Device ID | K193271 |
| 510k Number | K193271 |
| Device Name: | UAI EasyTriage-Rib |
| Classification | Radiological Computer-assisted Triage And Notification Software |
| Applicant | Shanghai United Imaging Intelligence Co., Ltd. No. 199, Huanke Road Shanghai, CN 201210 |
| Contact | Zhao Xiaojing |
| Correspondent | Zhao Xiaojing Shanghai United Imaging Intelligence Co., Ltd. No. 199, Huanke Road Shanghai, CN 201210 |
| Product Code | QAS |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-26 |
| Decision Date | 2021-01-15 |