Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)— 510(k) K243880

Name: FDA 510(k) clearance K243880
Creator: U.S. Food and Drug Administration
Published: 2025-06-17

Substantially Equivalent

Wuxi Hisky Medical Technologies Co., Ltd.

FDA 510(k) clearance K243880 for Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100), Substantially Equivalent on 2025-06-17. Applicant: Wuxi Hisky Medical Technologies Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wuxi Hisky Medical Technologies Co., Ltd.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2024-12-18
Decision date: 2025-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code IYO

view all

K253452 — Accuro 3S2026-07-24
K260190 — ARTHUR2026-06-18
K252237 — EdgeFlow UW202026-04-17
K254021 — Accuro XV2026-04-09
K253898 — QT Scanner 2000 Model A2026-03-04

More clearances from Wuxi Hisky Medical Technologies Co., Ltd.

view all

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.