510(k) K253720

uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite by Wuhan United Imaging Healthcare Co.,Ltd — Product Code IYN

K253720 is an FDA 510(k) premarket notification submitted by Wuhan United Imaging Healthcare Co.,Ltd for the device "uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite". The FDA issued a decision of Substantially Equivalent on May 21, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Wuhan United Imaging Healthcare Co.,Ltd has at least 1 other 510(k) clearance on record.