The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd. with the FDA for Udr 380i Pro.
| Device ID | K222339 |
| 510k Number | K222339 |
| Device Name: | UDR 380i Pro |
| Classification | System, X-ray, Mobile |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Contact | Xin Gao |
| Correspondent | Xin Gao Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-03 |
| Decision Date | 2022-09-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971576833276 | K222339 | 000 |