Wuxi Hisky Medical Technologies Co., Ltd.

Wuxi Hisky Medical Technologies Co., Ltd. specializes in shear wave elastography systems designed for non-invasive evaluation of liver fibrosis. Their portfolio includes hand-held extracorporeal ultrasound imaging transducers, dedicated hepatic ultrasound elastography systems, and specialized applicators for liver imaging. These devices use quantitative ultrasound to assess tissue stiffness, helping diagnose conditions like cirrhosis without invasive procedures.

The company operates from the United States, though its name includes 'Wuxi,' which may reference its origins or a regional focus. The manufacturing and regulatory presence are centered in the US, where its devices are developed and distributed.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry tracks Class II medical devices, ensuring traceability and compliance with US regulatory requirements. Listing in the UDI database is a standard step for devices authorized for commercial distribution in the US.

All of Wuxi Hisky Medical Technologies Co., Ltd.’s devices fall under Class II classification. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness, such as shear wave elastography systems used for diagnosing liver conditions.