The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd with the FDA for Uws-mr.
| Device ID | K192601 |
| 510k Number | K192601 |
| Device Name: | UWS-MR |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd No. 2258 Chengbei Rd., Jiading Industrial District 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 Jiading Industrial District Shanghai, CN 201807 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-20 |
| Decision Date | 2020-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971576834143 | K192601 | 000 |