FDA Registration
Active
🇨🇳 China
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
Reg #: 3011015597
·
FEI: 3011015597
·
Expires 2026
Products
12
Proprietary Names
41
Establishment Types
1
Classifications
12
Registration Details
- Registration Name
- SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
- Registration Number
- 3011015597
- FEI Number
- 3011015597
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.2258 Chengbei Rd. Jiading District
- City
- Shanghai
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K173001
Owner / Operator
- Firm Name
- Shanghai United Imaging Healthcare Co.,Ltd.
- Operator Number
- 10057992
- Address
- No.2258 Chengbei Rd. Jiading District
- City
- Shanghai
- State
- CN-SH
- Postal Code
- 201807
- Country
- CN
- Correspondent
- Shumei WANG
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2018-11-11 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2025-11-16 |
| System, X-Ray, Mobile | IZL | Class 2 | Radiology | No | 2023-02-17 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2018-09-04 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2025-07-25 |
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2025-07-25 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | Class 2 | Radiology | No | 2020-02-12 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2018-12-19 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2024-12-18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2019-09-15 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-06-18 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-06-18 |
Proprietary Names
uWS-CT
uDR Aurora CX
uWS-MR
uDR 380i Pro
uCT 530
uCT 550
uMR Omega
uPMR 790
uDR 780i
uOmniscan
uEXPLORER
uMI Panvivo
uWS-Angio
uCT ATLAS
uOmnispace
uMI Panorama 35
uMI Panorama 28
uMR 680
HYPER AiR
uMI Panvivo S
uCT 780
uMI Panorama GS
uDR 596i
uDR 592h
uMR Ultra
uOmnispace.CT
uMI 550
uWS-MI
uMI 780
HYPER DLR
HYPER Focus
uWS-Angio Pro
uMR Jupiter
uCT ATLAS Astound
uCT 760
uOmnispace.MR
uWS-Angio Basic
uDR Aris
uDR Arria
uAngio AVIVA CX
uOmnispace.MI
Establishment Types
Manufacture Medical Device