FDA 510(k) clearance · back to tracker

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

Wuxi Hisky Medical Technologies Co., Ltd. cleared K250026 on 2025-10-01, decision: substantially equivalent

K-number

K250026

Sponsor

Wuxi Hisky Medical Technologies Co., Ltd.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-10-01

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K250026on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.