Q: What types of medical devices does Shanghai United Imaging Healthcare Co., Ltd. manufacture?

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.

Question 1

What types of medical devices does Shanghai United Imaging Healthcare Co., Ltd. manufacture?

Accepted Answer

Shanghai United Imaging Healthcare Co., Ltd. manufactures radiology software for DICOM image processing, including full-body MRI and CT systems with superconducting magnets, as well as PET/CT combinations. Their portfolio also includes mobile and stationary digital X-ray systems for basic diagnostics and specialized MRI application software for imaging analysis.

The company’s devices are classified under EU Medical Device Regulations as Class II and Class IIa/IIb, with listings in the EUDAMED registry, FDA’s 510(k) and UDI databases. The manufacturer is based in China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Shanghai United Imaging Healthcare Co., Ltd. based, and how does this affect its regulatory listings?

Accepted Answer

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.

Question 3

How are Shanghai United Imaging Healthcare Co., Ltd.’s devices classified under EU regulations?

Accepted Answer

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.

Question 4

Which regulatory registries list Shanghai United Imaging Healthcare Co., Ltd.’s devices?

Accepted Answer

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.

Question 5

What distinguishes Shanghai United Imaging Healthcare Co., Ltd.’s MRI and CT systems from other manufacturers?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Positron Emission Tomography and Computed Tomography System	88002589	EUDAMED	Class IIb	Active
Magnetic Resonance Imaging System	88001215	EUDAMED	Class IIa	Active
18011487	18011487	EUDAMED	Class IIb	Active
Magnetic Resonance Imaging System	88002028	EUDAMEDFDA UDI	Class IIa	Active
uWS-Angio Pro Software	88000900	EUDAMED	Class IIa	Active
88000090	88000090	EUDAMED	Class IIb	Active
88001296	88001296	EUDAMEDFDA UDI	Class IIa	Active
88001297	88001297	EUDAMEDFDA UDI	Class IIa	Active
Computed Tomography X-ray System	88001125	EUDAMED	Class IIb	Active
88000057	88000057	EUDAMEDFDA UDI	Class IIb	Active
88000684	88000684	EUDAMED	Class IIb	Active
Magnetic Resonance Imaging System	uMR 580	EUDAMED	Class IIa	Active
uOmniscan	88002494	EUDAMEDFDA UDI	Class IIa	Active
88000752	88000752	EUDAMED	Class IIb	Active
Positron Emission Tomography and Computed Tomography System	88000908	EUDAMEDFDA UDI	Class IIb	Active
88000843	88000843	EUDAMED	Class IIa	Active
88000654	88000654	EUDAMEDFDA UDI	Class IIa	Active
Positron Emission Tomography and Computed Tomography System	88000025	EUDAMEDFDA UDI	Class IIb	Active
88000054	88000054	EUDAMEDFDA UDI	Class IIb	Active
88001082	88001082	EUDAMEDFDA UDI	Class IIa	Active
Computed Tomography X-ray System	-	EUDAMED	Class IIb	Active
Magnetic Resonance Imaging System	88000220	EUDAMEDFDA UDI	Class IIa	Active
88000741	88000741	EUDAMEDFDA UDI	Class IIa	Active
Positron Emission Tomography and Computed Tomography System	88000914	EUDAMEDFDA UDI	Class IIb	Active
Magnetic Resonance Imaging System	88000099	EUDAMED	Class IIa	Active
88001398	88001398	EUDAMED	Class IIb	Active
88000993	88000993	EUDAMEDFDA UDI	Class IIb	Active
88000845	88000845	EUDAMED	Class IIa	Active
88001399	88001399	EUDAMED	Class IIb	Active
88000653	88000653	EUDAMED	Class IIa	Active
Positron Emission Tomography and Computed Tomography System	88001221	EUDAMEDFDA UDI	Class IIb	Active
Computed Tomography X-ray System	88000817	EUDAMEDFDA UDI	Class IIb	Active
88000075	88000075	EUDAMED	Class IIa	Active
88000050	88000050	EUDAMED	Class IIb	Active
Positron Emission Tomography and Computed Tomography System	88000922	EUDAMEDFDA UDI	Class IIb	Active
Computed Tomography X-ray System	80513129	EUDAMEDFDA UDI	Class IIb	Active
88000010	88000010	EUDAMED	Class IIb	Active
Computed Tomography X-ray System	88000855	EUDAMEDFDA UDI	Class IIb	Active
uWS-Angio Software	88000900	EUDAMEDFDA UDI	Class IIa	Active
88000647	88000647	EUDAMED	Class IIb	Active
88000196	88000196	EUDAMEDFDA UDI	Class IIa	Active
88000751	88000751	EUDAMED	Class IIb	Active
88002023	88002023	EUDAMED	Class IIa	Active
Medical Linear Accelerator System	Class llb	EUDAMED	Class IIb	Active
Positron Emission Tomography and Computed Tomography System	88000192	EUDAMED	Class IIb	Active
88000223	88000223	EUDAMED	Class IIb	Active
88000720	88000720	EUDAMED	Class IIb	Active
Positron Emission Tomography and Computed Tomography System	88002709	EUDAMED	Class IIb	Active
Radiation therapy treatment planning system	88002057	EUDAMED	Class IIb	Active
88001298	88001298	EUDAMEDFDA UDI	Class IIa	Active

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