Sonocine, Inc.

Sonocine, Inc. specializes in breast ultrasound imaging systems. These devices are designed specifically for diagnostic imaging of breast tissue, combining hardware and software to capture and analyze ultrasound images. Examples include the SonoCine Image Acquisition Station and the SONOCINE ADJUNCTIVE BREAST ULTRASOUND SYSTEM (ABU), Model 100.

Sonocine, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and operational reach, particularly in markets where U.S.-based manufacturers are subject to specific oversight requirements.

Sonocine, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries are critical for tracking and evaluating medical devices under U.S. regulatory oversight, ensuring transparency and compliance with classification standards.

Sonocine, Inc.’s devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device, where Class II devices require special controls to ensure safety and effectiveness beyond general controls, such as good manufacturing practices.