UMR Omega
System, Nuclear Magnetic Resonance Imaging
Shanghai United Imaging Healthcare Co., Ltd.
The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd. with the FDA for Umr Omega.
Pre-market Notification Details
| Device ID | K193200 |
| 510k Number | K193200 |
| Device Name: | UMR Omega |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. NO. 2258 Chengbei Road, Shanghai, CN 201807 |
| Contact | Xin Gao |
| Correspondent | Xin Gao Shanghai United Imaging Healthcare Co., Ltd. NO. 2258 Chengbei Road, 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 | 2019-11-20 |
| Decision Date | 2020-03-27 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971576830114 | K193200 | 000 |
Trademark Results [UMR Omega]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UMR OMEGA 88712504 not registered Live/Pending |
Shanghai United Imaging Healthcare Co.,Ltd. 2019-12-02 |
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