The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd. with the FDA for Umi 550 Pet/ct System.
| Device ID | K182237 |
| 510k Number | K182237 |
| Device Name: | UMI 550 PET/CT 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 | 2018-08-17 |
| Decision Date | 2018-10-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971576832026 | K182237 | 000 |
| 06971576832057 | K182237 | 000 |