The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co.,ltd. with the FDA for Umr 570.
| Device ID | K180925 |
| 510k Number | K180925 |
| Device Name: | UMR 570 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Road., Jiading Industrial District Shanghai, CN 201807 |
| Contact | Shumei Wang |
| Correspondent | Shumei Wang Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Road., Jiading Industrial District Shanghai, CN 201807 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-09 |
| Decision Date | 2018-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971576830015 | K180925 | 000 |