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

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..

Clearance details

Applicant: Wuxi Hisky Medical Technologies Co., Ltd.
Product code: Code IYO
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 ↗

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.