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 · K253716 · 2026-05-15

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, listed by FDA (510(k), K253716) with a decision date of 2026-05-15. Review panel: Radiology.

FDA submission numberK253716
Pathway510(k)
CompanyWuhan United Imaging Healthcare Co.,Ltd
Review panel (specialty)Radiology
FDA decision date2026-05-15
DecisionSubstantially Equivalent
Product codeIYN
ClassificationSystem, Imaging, Pulsed Doppler, Ultrasonic
Device class2
Regulation number892.1550
Review time (calendar days)172
Applicant countryCN

Official FDA database record · FDA AI-enabled device list

All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.