Data / Medical devices / China / Wuhan United Imaging Healthcare Co.,Ltd.
Wuhan United Imaging Healthcare Co.,Ltd.: FDA-registered device maker in Wuhan Hubei, China, 2 510(k) clearances
Wuhan United Imaging Healthcare Co.,Ltd. is registered with the FDA (registration 3021970996) in Wuhan Hubei, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3021970996
- Address
- No.99 Gaokeyuan Road, East Lake High-tech Development Zone, Wuhan Hubei, China, 430206
- Owner or operator
- Shanghai United Imaging Healthcare Co.,Ltd. (10057992)
- Roles
- Manufacturer
- First device listed
- May 27, 2026
- Registered through
- 2027
- Brand names listed
- uSONIQUE Genesis, uSONIQUE Genesis Elite, uSONIQUE Genesis Pro, uSONIQUE Genesis Super, uSONIQUE Grace, uSONIQUE Grace Elite, uSONIQUE Nova, uSONIQUE Nova Elite and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2026 | K253720 | uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite | IYN | Substantially Equivalent | Wuhan United Imaging Healthcare Co.,Ltd | accessdata.fda.gov |
| May 15, 2026 | K253716 | uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super | IYN | Substantially Equivalent | Wuhan United Imaging Healthcare Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of Automated Radiological Image Processing Software
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.