The following data is part of a premarket notification filed by Shanghai United Imaging Healthcare Co., Ltd. with the FDA for Uct Atlas With Uws-ct-dual Energy Analysis.
| Device ID | K203448 |
| 510k Number | K203448 |
| Device Name: | UCT ATLAS With UWS-CT-Dual Energy Analysis |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Contact | Xin Gao |
| Correspondent | Xin Gao Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengei Rd., Jiading Industrial District Shanghai, CN 201807 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-23 |
| Decision Date | 2021-08-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971576831104 | K203448 | 000 |
| 06971576834150 | K203448 | 000 |