The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd with the FDA for Umr 780.
| Device ID | K193176 |
| 510k Number | K193176 |
| Device Name: | UMR 780 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai, CN 201807 |
| Contact | Xin Gao |
| Correspondent | Xin Gao Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, 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 | 2019-11-18 |
| Decision Date | 2020-05-05 |