Shanghai United Imaging Healthcare Co., Ltd.

Shanghai United Imaging Healthcare Co., Ltd. specializes in radiology-related devices, including DICOM image processing software for medical imaging analysis. Their product portfolio also covers full-body MRI systems with superconducting magnets, full-body CT systems, PET/CT combinations, and digital X-ray systems—both mobile and stationary—for basic diagnostic imaging. Additionally, they provide specialized MRI application software for enhanced imaging workflows.

The company is headquartered in China. Due to its global market presence, its devices are listed in key international regulatory databases, including EUDAMED for EU compliance tracking, FDA’s 510(k) premarket notifications, and FDA’s UDI (Unique Device Identification) database, ensuring transparency for regulatory authorities and healthcare providers worldwide.

Under the EU Medical Device Regulations, Shanghai United Imaging Healthcare Co., Ltd.’s devices are primarily classified as Class II (moderate risk) or Class IIa/IIb (higher risk, depending on the device). This classification is determined by factors like the device’s intended purpose, duration of use, and potential risks to patients, influencing the regulatory scrutiny and compliance requirements they must meet.

The company’s devices are included in EUDAMED, the European Union’s medical device registry, which tracks compliance and market surveillance data. Additionally, they appear in the FDA’s 510(k) database (for premarket submissions in the US) and the FDA’s UDI system, which assigns unique identifiers to medical devices for global traceability and regulatory tracking.

The company’s MRI and CT systems are designed with superconducting magnets for full-body imaging, which enhances image resolution and diagnostic capabilities compared to conventional systems. Their portfolio also integrates PET/CT combinations for hybrid imaging, as well as specialized MRI application software to streamline workflows and improve diagnostic accuracy. These features align with advanced radiology solutions targeting high-performance clinical environments.