Devices · Wuhan United Imaging Healthcare Co.,Ltd
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
Wuhan United Imaging Healthcare Co.,Ltd is listed for 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 (K253716). The FDA list gives May 15, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYN. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253716
- Date of final decision
- May 15, 2026
- Company on the FDA list
- Wuhan United Imaging Healthcare Co.,Ltd
- Lead panel
- Radiology
- Primary product code
- IYN
- openFDA device name for the code
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device class
- 2
- Regulation number
- 892.1550
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary