The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd. with the FDA for Upmr 790.
| Device ID | K183014 |
| 510k Number | K183014 |
| Device Name: | UPMR 790 |
| Classification | Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Contact | Shumei Wang |
| Correspondent | Shumei Wang Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Product Code | OUO |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-31 |
| Decision Date | 2019-02-27 |
| Summary: | summary |