510(k) K253720

Device: uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite
Applicant: Wuhan United Imaging Healthcare Co.,Ltd
510(k) number: K253720
Product code: IYN
Decision: Substantially Equivalent (SESE)
Decision date: 2026-05-21
Date received: 2025-11-24
Regulation: 892.1550
Classification name: System, Imaging, Pulsed Doppler, Ultrasonic
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Related Records

Applicant Contact

Contact: Xin GAO
Address: #99 Gaokeyuan Rd.,East Lake High-Tech Development Zone Wuhan CN 430206 430206

FDA Registration Numbers

3033527241
9710602
3005810333
3003774756
3011162972
2029275
3004705634
3007194257
3002183074
3034232408
3014680735
3006441164
3004485675
3013844297
8041160
3015525240
3017955833
3006680097
3009499478
3042225166
3003600763
3017487805
1066270
8043933
3011688715
3011416394
3014574557
1937397
8010047
3011050570
3015997711
3010400367
3015499445
3004752776
3032008018
3006260740
3018094310
3009758186
3010102386
3011686611
3009196578
3006985147
3009247326
3008492462
3031823165
3019784575
3003412859
3006161756
2245304
3010220244
3003851073
3009286597
3003681187
2532090
3013041594
3010398867
3025786376
3003591740
3016854601
9680269
3026405201
2939830
3005403518
3000976525
3008487708
3005049530
9610482
3010703925
3014745562
3015276088
3029937167
3043534483
3035950510
2134213
3009293490
3014302721
3025429169
3033508292
3007994837

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code IYN

510(k)	Device	Applicant	Decision date
K253949	SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6	CHISON Medical Technologies Co., Ltd.	2026-05-22
K254028	Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T)	Sonoscape Medical Corp.	2026-05-15
K253716	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	2026-05-15
K260111	Palmtop Ultrasound Diagnostic System (MT10P/MT10)	Mytech Intelligence (Shenzhen) Co., Ltd.	2026-05-14
K260846	Diagnostic Ultrasound System (MU9);Diagnostic Ultrasound System (MU9S);Diagnostic Ultrasound System (MU9T);Diagnostic Ultrasound System (MU9 Exp);Diagnostic Ultrasound System (MU9 Pro);Diagnostic Ultrasound System (MU9 Super);Diagnostic Ultrasound System (MU9P);Diagnostic Ultrasound System (MU9A);Diagnostic Ultrasound System (MU7);Diagnostic Ultrasound System (MU7S);Diagnostic Ultrasound System (MU7T);Diagnostic Ultrasound System (MU7 Exp);Diagnostic Ultrasound System (MU7 Pro);Diagnos	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	2026-05-11
K261132	Healium Intelliscan LX192LC	Healium Intelliscan Corporation	2026-05-05
K252558	Lumify Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-05-05
K260589	ES-Series	E-Scopics	2026-04-29
K253288	6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)	Esaote, S.p.A.	2026-04-06
K252709	Wireless Probe Type Ultrasound Scanner	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	2026-04-02
K253595	EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System	Philips Ultrasound, LLC	2026-03-27
K254099	EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System	Samsung Medison Co., Ltd.	2026-03-27
K252148	Butterfly Gestational Age Tool	Butterfly Network, Inc.	2026-03-27
K260673	LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power	GE Medical Systems Ultrasound and Primary Care Diagnostics	2026-03-24
K252433	Sonio Detect (v3)	Sonio	2026-03-16