The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co.,ltd. with the FDA for Umc 560i.
| Device ID | K183144 |
| 510k Number | K183144 |
| Device Name: | UMC 560i |
| Classification | Interventional Fluoroscopic X-ray System |
| Applicant | Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Contact | Shumei Wang |
| Correspondent | Gao Xin Shanghai United Imaging Healthcare Co.,Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Product Code | OWB |
| Subsequent Product Code | JAA |
| Subsequent Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-13 |
| Decision Date | 2019-12-19 |