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Sign in to claim this brandShanghai United Imaging Healthcare Co., Ltd.
China·CN-MF-000008501
Last updated September 17, 2026
What Shanghai United Imaging Healthcare Co., Ltd. makes
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.
Frequently asked questions
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.
Where is Shanghai United Imaging Healthcare Co., Ltd. based, and how does this affect its regulatory listings?
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.
How are Shanghai United Imaging Healthcare Co., Ltd.’s devices classified under EU regulations?
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.
Which regulatory registries list Shanghai United Imaging Healthcare Co., Ltd.’s devices?
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.
What distinguishes Shanghai United Imaging Healthcare Co., Ltd.’s MRI and CT systems from other manufacturers?
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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- China
- Address
- 2258, Chengbei Road, Jiading District, Shanghai, China
- Website
- united-imaging.com
- —
- —
- [email protected]
- Phone
- +1(855) 221-1552
- PRRC Contact
- Shumei Wang
- EUDAMED SRN
- CN-MF-000008501
- FDA FEI Number
- 3011015597
- DUNS Number
- 421271328
Catalogue (110)
Page 1 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Positron Emission Tomography and Computed Tomography System | 88002621 | EUDAMED | Class IIb | Active |
| 88002559 | 88002559 | EUDAMED | Class IIb | Active |
| 88002577 | 88002577 | EUDAMED | Class IIb | Active |
| uCT | uCT ATLAS Astound | FDA UDI | Class II | Active |
| uMI | uMI Panvivo S | FDA UDI | Class II | Active |
| uWS | uWS-MI | FDA UDI | Class II | Active |
| uDR | uDR 380i Pro | FDA UDI | Class II | Active |
| uWS | uWS-MR | FDA UDI | Class II | Active |
| uMI | uMI 550 | FDA UDI | Class II | Active |
| uWS | uWS-MR | FDA UDI | Class II | Active |
| uWS | uWS-CT | FDA UDI | Class II | Active |
| uCT | uCT 530 | FDA UDI | Class II | Active |
| uMR | uMR 570 | FDA UDI | Class II | Active |
| uDR | uDR 780i | FDA UDI | Class II | Active |
| uCT | uCT ATLAS | FDA UDI | Class II | Active |
| uWS | uWS-CT | FDA UDI | Class II | Active |
| 88000758 | 88000758 | EUDAMED | Class IIb | Active |
| 88000777 | 88000777 | EUDAMED | Class IIb | Active |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis | K223028 | FDA 510(k) | Class II | Active |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis | K243617 | FDA 510(k) | Class II | Active |
| uMR 570 | K230758 | FDA 510(k) | Class II | Active |
| uMR 560 | K180926 | FDA 510(k) | Class II | Active |
| uCT 530, uCT 550 | K200016 | FDA 510(k) | Class II | Active |
| uMR 790 | K181371 | FDA 510(k) | Class II | Active |
| uMR 780, uMR 790 | K191157 | FDA 510(k) | Class II | Active |
| Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 | K183186 | FDA 510(k) | Class II | Active |
| uMR 580, uMR 588 | K183137 | FDA 510(k) | Class II | Active |
| uMR Omega with uWS-MR-MRS | K220332 | FDA 510(k) | Class II | Active |
| HYPER Focus | K210418 | FDA 510(k) | Class II | Active |
| uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis | K231482 | FDA 510(k) | Class II | Active |
| uCT 530, uCT 550 | K181414 | FDA 510(k) | Class II | Active |
| uMI 780 PET/CT System | K172143 | FDA 510(k) | Class II | Active |
| Hyper Dlr | K193210 | FDA 510(k) | Class II | Active |
| uCT ATLAS with uWS-CT-Dual Energy Analysis | K203448 | FDA 510(k) | Class II | Active |
| Medical Image Post-processing Software (uOmnispace.CT) | K242624 | FDA 510(k) | Class II | Active |
| uCT 780 with uWS-CT-Dual Energy Analysis | K253173 | FDA 510(k) | Class II | Active |
| Deep Recon | K193073 | FDA 510(k) | Class II | Active |
| uDR 592h, uDR 596i | K181413 | FDA 510(k) | Class II | Active |
| uMR 570 | K180925 | FDA 510(k) | Class II | Active |
| uMR 570 | K200024 | FDA 510(k) | Class II | Active |
| uMI 550 PET/CT System | K182237 | FDA 510(k) | Class II | Active |
| uCT 520, uCT 528 | K183143 | FDA 510(k) | Class II | Active |
| HYPER AiR | K210001 | FDA 510(k) | Class II | Active |
| uMR570 | K201540 | FDA 510(k) | Class II | Active |
| uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis | K230162 | FDA 510(k) | Class II | Active |
| uDR 592h, uDR 596i | K192293 | FDA 510(k) | Class II | Active |
| uDR Arria & uDR Aris | K252000 | FDA 510(k) | Class II | Active |
| uDR Aurora CX | K251167 | FDA 510(k) | Class II | Active |
| Positron Emission Tomography and Computed Tomography System | 88002513 | EUDAMED | Class IIb | Active |
| 88000721 | 88000721 | EUDAMED | Class IIb | Active |
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