The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd with the FDA for Emission Computed Tomography System.
| Device ID | K193241 |
| 510k Number | K193241 |
| Device Name: | Emission Computed Tomography System |
| Classification | System, Tomography, Computed, Emission |
| 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 | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-25 |
| Decision Date | 2020-01-26 |