The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd. with the FDA for Uws-mr.
| Device ID | K183164 |
| 510k Number | K183164 |
| Device Name: | UWS-MR |
| Classification | System, Image Processing, Radiological |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. NO.2258 Chengbei Road Shanghai, CN 201807 |
| Contact | Xin Gao |
| Correspondent | Xin Gao Shanghai United Imaging Healthcare Co., Ltd. NO.2258 Chengbei Road Jiading District Shanghai, CN 201807 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2019-03-22 |