FDA Registration
Inactive
🇨🇳 China
Wuhan United Imaging Healthcare Co.,Ltd.
·
Expires 2026
Products
4
Proprietary Names
18
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Wuhan United Imaging Healthcare Co.,Ltd.
- Status
- Inactive
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.99 Gaokeyuan Road, East Lake High-tech Development Zone
- City
- Wuhan Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K253716
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, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2026-05-27 |
| Automated Radiological Image Processing Software | QIH | Class 2 | Radiology | No | 2026-05-27 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2026-05-27 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2026-05-27 |
Proprietary Names
uSONIQUE Genesis Super
uSONIQUE Genesis
uSONIQUE Pulse Elite
uSONIQUE Pulse Super
uSONIQUE Genesis Elite
uSONIQUE Venus Pro
uSONIQUE Pulse
uSONIQUE Genesis Pro
uSONIQUE Pulse Pro
uSONIQUE Venus Super
uSONIQUE Venus
uSONIQUE Venus Elite
uSONIQUE Nova Elite
uSONIQUE Vita Elite
uSONIQUE Nova
uSONIQUE Grace
uSONIQUE Grace Elite
uSONIQUE Vita
Establishment Types
Manufacture Medical Device