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 is an AI-enabled medical device from Wuhan United Imaging Healthcare Co.,Ltd that the U.S. FDA cleared through 510(k) K253716 on May 15, 2026. Its lead review panel is Radiology and its primary product code is IYN (System, Imaging, Pulsed Doppler, Ultrasonic).
See also FDA-cleared AI radiology devices in 2026, all FDA AI clearances in 2026, top radiology AI devices.
Key facts
| Submission number | K253716 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Wuhan United Imaging Healthcare Co.,Ltd |
| Lead review panel | Radiology |
| Primary product code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant (openFDA) | Wuhan United Imaging Healthcare Co.,Ltd |
| Applicant location | Wuhan, CN |
| Device class | Class 2 |
| Regulation number | 21 CFR 892.1550 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. 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 went through this pathway (K253716).
openFDA lists it as a Class 2 device under 21 CFR 892.1550. Class II devices are moderate risk and are subject to general and special controls.
Product code IYN covers 124 devices on the FDA AI list. By decision date, this device is #119 of 124 under that code. Wuhan United Imaging Healthcare Co.,Ltd has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.
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