The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co.,ltd. with the FDA for Udr 592h, Udr 596i.
| Device ID | K181413 |
| 510k Number | K181413 |
| Device Name: | UDR 592h, UDR 596i |
| Classification | System, X-ray, Stationary |
| 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 | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-30 |
| Decision Date | 2018-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971576833023 | K181413 | 000 |