The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd with the FDA for Umr 780.
|Device Name:||UMR 780|
|Classification||System, Nuclear Magnetic Resonance Imaging|
|Applicant||Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai, CN 201807|
Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd, Shanghai, CN 201807
|CFR Regulation Number||892.1000 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|