Name: Predicase
Price: 199 USD

K-number	K250026
Device name	Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000)
Applicant	Wuxi Hisky Medical Technologies Co., Ltd.
Product code	IYN
Device class	Class II
Decision date	Oct 1, 2025
Decision	Substantially Equivalent
Regulation	892.1550

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.