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FDA 510(k)

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)

K-Number: K243880 · 2025-06-17

ApplicantWuxi Hisky Medical Technologies Co., Ltd.
Decision Date2025-06-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) is a medical device manufactured by Wuxi Hisky Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-06-17 under approval number K243880. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)?

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) is a medical device that received FDA 510(k) clearance on 2025-06-17. It is manufactured by Wuxi Hisky Medical Technologies Co., Ltd.. The 510(k) number is K243880.

When was Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) approved by the FDA?

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) received FDA 510(k) clearance on 2025-06-17, under approval number K243880.

What company makes Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)?

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) is manufactured by Wuxi Hisky Medical Technologies Co., Ltd..

What is the FDA product code for Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)?

The FDA product code for Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) is IYO.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT07613944 Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders NOT_YET_RECRUITING NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED

Other Devices by Wuxi Hisky Medical Technologies Co., Ltd.

K173595Shear Wave Quantificational Ultrasound Diagnostic System K200136Shear Wave Quantificational Ultrasound Diagnostic System K250026Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System (BrightP960); Confocal Microprobe Imaging System (BrightP880); Confocal Microprobe Imaging System (BrightP860); Confocal Microprobe Imaging System (BrightP780); Confocal Microprobe Imaging System (BrightP750); Confocal Microprobe Imaging System (BrightP680); Confocal Microprobe Imaging System (BrightP660); Confocal Microprobe Imaging System (BrightP600); Confocal Microprobe Imaging System (BrightP580);

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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