GE Medical Systems (China) Co., Ltd.

GE Medical Systems (China) Co., Ltd. specializes in ultrasound imaging systems. Their portfolio includes general-purpose models like the LOGIQ and Vivid series, which are designed for a broad range of diagnostic applications, as well as specialized cardiovascular-focused systems such as the Venue and Versana series. These devices are engineered to provide detailed imaging for various medical evaluations, including cardiac and vascular assessments.

GE Medical Systems (China) Co., Ltd. is based in the US, though the company name includes 'China' in its title, which may refer to its operational or manufacturing presence there. The devices it manufactures are classified as Class II under regulatory frameworks, indicating a moderate level of risk that requires compliance with specific controls. Their regulatory records include submissions for FDA 510(k) clearance and UDI (Unique Device Identification) compliance, ensuring traceability and regulatory transparency for these imaging systems.

The ultrasound devices produced by GE Medical Systems (China) Co., Ltd. are documented in the FDA 510(k) registry and the FDA UDI (Unique Device Identification) database. These registries track premarket submissions and device identification records, respectively, ensuring transparency and compliance with US regulatory requirements for medical imaging systems.

The ultrasound devices manufactured by GE Medical Systems (China) Co., Ltd. fall under Class II classification in regulatory frameworks. This classification is assigned based on the level of risk associated with the device—Class II devices are considered to have a moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. This classification applies to both general-purpose and cardiovascular-focused ultrasound systems, such as those in the LOGIQ, Vivid, Venue, and Versana series.