The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co.,ltd. with the FDA for Umr Omega With Uws-mr-mrs.
| Device ID | K220332 |
| 510k Number | K220332 |
| Device Name: | UMR Omega With UWS-MR-MRS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Shanghai United Imaging Healthcare Co.,Ltd. NO.2258 Chengbei Road, Jiading District 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 | LNH |
| Subsequent Product Code | LLZ |
| Subsequent Product Code | QIH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-04 |
| Decision Date | 2022-10-27 |