The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd. with the FDA for Umr 580, Umr 588.
| Device ID | K183137 |
| 510k Number | K183137 |
| Device Name: | UMR 580, UMR 588 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Contact | Xin Gao |
| Correspondent | Xin Gao Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-01-11 |
| Summary: | summary |