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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K253720
Device Name uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Applicant
Wuhan United Imaging Healthcare Co.,Ltd
#99 Gaokeyuan Rd.,East Lake High-Tech Development Zone
Wuhan,  CN 430206
Applicant Contact Xin GAO
Correspondent
Wuhan United Imaging Healthcare Co.,Ltd
#99 Gaokeyuan Rd.,East Lake High-Tech Development Zone
Wuhan,  CN 430206
Correspondent Contact Xin GAO
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received11/24/2025
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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