Cleared Traditional

Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)

K250026 · Wuxi Hisky Medical Technologies Co., Ltd. · Radiology
Oct 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K250026 is an FDA 510(k) clearance for the Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000), a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Wuxi Hisky Medical Technologies Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on October 1, 2025, 268 days after receiving the submission on January 6, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.

Submission Details

510(k) Number K250026 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 2025
Decision Date October 01, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1550

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