Caresono Technology Co., Ltd.

Caresono Technology Co., Ltd. specializes in bladder volume ultrasound imaging systems, which are designed for non-invasive measurement of bladder volume. These devices are primarily used in clinical settings to evaluate urinary retention or post-void residual volume, helping healthcare providers diagnose and manage lower urinary tract conditions.

The company is headquartered in the United States, where it develops and manufactures its ultrasound-based bladder volume measurement devices. This location ensures compliance with U.S. regulatory standards for medical devices.

Caresono’s devices fall under Class II classification in the U.S., meaning they pose moderate risk and require special controls to ensure safety and effectiveness. This classification applies to diagnostic ultrasound systems like their bladder volume scanners, which are regulated through pathways such as the FDA’s 510(k) process and Unique Device Identification (UDI) requirements.

Caresono’s devices are listed in FDA registries, including the 510(k) premarket notification database and the UDI (Unique Device Identifier) system. These registries track authorized medical devices in the U.S., ensuring transparency and compliance with regulatory requirements for diagnostic imaging tools.