FDA.report

510(k) K243880

Device
Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)
Applicant
Wuxi Hisky Medical Technologies Co., Ltd.
510(k) number
K243880
Product code
IYO
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-17
Date received
2024-12-18
Regulation
892.1560
Classification name
System, Imaging, Pulsed Echo, 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
Jinhua Shao
Address
Rm. B401, 530 Plz., University Science Park, Taihu Internati Wuxi CN 214135 214135

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code IYO

510(k)DeviceApplicantDecision date
K252237EdgeFlow UW20Edgecare, Inc.2026-04-17
K254021Accuro XVRivanna Medical, Inc.2026-04-09
K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.2026-03-04
K253714IntraSight PlusPhilips Image Guided Therapy Corporation2026-02-24
K253221Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro)Eieling Technology (Shenzhen) Limited2026-02-06
K250331Astrasono A3Pro Bladder Scanner (A3Pro)Astrasono Technology Co., Ltd.2025-09-30
K250381Deepsight NeedleVue LC1 Ultrasound SystemDeepSight Technology, Inc.2025-08-01
K243227B-ScanAccutome, Inc. Doing Business AS Keeler USA2025-07-11
K251728Velacur One (LI-1100)Sonic Incytes Medical Corp2025-06-26
K243937Accuro 3SRivanna Medical, Inc.2025-05-23
K243479EchoGuide (Version 1)Sonavex, Inc.2025-04-23
K242496Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C)Eieling Technology (Shenzhen) Limited2024-11-19
K241029SpineUs™ SystemVerdure Imaging2024-10-07
K233977VelacurSonic Incytes2024-09-04
K233579SC1 Handheld Ultrasound Imaging system (Model: SC1)Fcu Co., Ltd.2024-06-26