# Wuhan United Imaging Healthcare Co.,Ltd. (manufacturer, Wuhan Hubei, CN): 8 new FDA device listings, incl. system, imaging, pulsed echo, ultrasonic

**Score:** 75/100

| Field | Value |
|---|---|
| Establishment | Wuhan United Imaging Healthcare Co.,Ltd. |
| Owner / operator | Shanghai United Imaging Healthcare Co.,Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Wuhan Hubei, CN |
| New listings | 8 |
| Devices | System, Imaging, Pulsed Echo, Ultrasonic; Automated Radiological Image Processing Software; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic |
| Product codes | IYO, QIH, ITX, IYN |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | uSONIQUE Pulse; uSONIQUE Genesis Elite; uSONIQUE Pulse Super; uSONIQUE Venus Super; uSONIQUE Pulse Elite; uSONIQUE Venus; uSONIQUE Venus Elite; uSONIQUE Pulse Pro |
| First new listing | 2026-05-27 |
| Latest new listing | 2026-06-04 |
| FDA registration number | 3021970996 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.