Identifiers
- 510(k) Number
- K183143 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The uCT 520 and uCT 528 are 40-slice computed tomography (CT) X-ray systems designed for high-resolution imaging. These devices provide detailed cross-sectional views of the body, enabling diagnostic evaluation of internal structures with enhanced clarity and efficiency. The systems incorporate advanced detector technology and workflow optimisation to support a range of clinical applications, including cardiovascular, neurological, and abdominal imaging.
The uCT 520 and uCT 528 are intended for use in hospital and research settings, supplied as standalone systems with integrated software interfaces for operation and maintenance. Both models are classified under the product code JAK and have received FDA 510(k) clearance as substantially equivalent, along with MDD compliance. They are not specified as single-use or reusable, and no MRI safety information is provided. Storage and handling instructions are detailed in the operator manual, which covers safety, maintenance, and system operations.
Frequently asked questions
What clinical applications are these CT systems primarily designed to support, and how do they improve diagnostic imaging?
The uCT 520 and uCT 528 are engineered for high-resolution imaging across cardiovascular, neurological, and abdominal applications. Their 40-slice detector technology delivers detailed cross-sectional views, enhancing clarity and efficiency for evaluating internal structures. Advanced workflow optimisation streamlines operations, making them suitable for complex diagnostic evaluations in hospital and research environments.
Are these systems intended for single-use or reusable in clinical settings, and what does that mean for maintenance?
The uCT 520 and uCT 528 are not specified as single-use or reusable, meaning they are designed for repeated use in clinical settings. Maintenance details, including cleaning, calibration, and servicing, are covered in the operator manual provided with the system. Proper adherence to these guidelines ensures optimal performance and longevity.
How are these CT systems supplied, and what kind of infrastructure do they require for installation?
The uCT 520 and uCT 528 are supplied as standalone systems, meaning they come fully integrated with necessary hardware and software interfaces for operation and maintenance. They are intended for hospital or research settings, so they require appropriate electrical power, ventilation, and space to accommodate the system’s dimensions and operational needs as outlined in the operator manual.
What regulatory pathways have these CT systems undergone, and how does that affect their use in different markets?
The uCT 520 and uCT 528 have received FDA 510(k) clearance under the Traditional pathway, with a decision of *Substantially Equivalent* (SESE) by the Radiology Advisory Committee (RA). They also comply with the Medical Device Directive (MDD). This means they are approved for use in the U.S. market under FDA regulations and can be marketed in regions adhering to MDD standards, though buyers should verify local compliance requirements.
Do these systems include any specific safety considerations for MRI environments, and if not, what precautions should be taken?
The uCT 520 and uCT 528 are not specified as MRI-safe or MRI-compatible, meaning they were not designed or tested for use in MRI environments. Clinicians should ensure these systems are installed and operated in non-MRI areas to avoid interference or safety risks. Always follow the operator manual’s safety guidelines to prevent potential hazards.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: uCT 520/528 Software Operator Manual | PDF | Ct Scan | Page Layout - Scribd, uCT 520 (High Efficiency+Low Cost) | United-Imaging Healthcare, uCT 528 - United-Imaging, uCT 520 (High Efficiency+Low Cost) | United-Imaging Healthcare
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K183143 | Class II | Active |
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Manufacturer
- Manufacturer
- Shangai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K183143 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026