FDA 510(k) clearance · back to tracker

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

Wuxi Hisky Medical Technologies Co., Ltd. cleared K243880 on 2025-06-17, decision: substantially equivalent

K-number

K243880

Sponsor

Wuxi Hisky Medical Technologies Co., Ltd.

Device

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

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-06-17

Product code

IYO

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1560

Official FDA record

Open K243880on accessdata.fda.gov →

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

openFDA JSON

Raw record →

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.