Identifiers
- 510(k) Number
- K251167 FDA 510(k)
- FDA Product Code
- KPR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1680 FDA 510(k)
- Regulation Number
- 892.1680 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The uDR Aurora CX is a stationary X-ray imaging system designed for high-resolution radiography and computed tomography (CT) applications. It integrates advanced detector technology and multi-slice capabilities to deliver detailed cross-sectional imaging for diagnostic purposes in radiology settings.
This device is supplied as a reusable, non-sterile medical system intended for use in clinical radiology departments. It operates within MRI-safe parameters for the specified configurations and is authorised under FDA 510(k) clearance and MDR compliance. The system includes multiple FEI numbers (e.g., 3003768277) and is classified as a Class II medical device, adhering to regulatory standards for X-ray imaging systems.
Frequently asked questions
What types of imaging does the uDR Aurora CX support, and how does its advanced detector technology benefit clinical workflows?
The uDR Aurora CX is designed for high-resolution radiography and computed tomography (CT) applications, enabling detailed cross-sectional imaging. Its advanced detector technology and multi-slice capabilities enhance diagnostic clarity, improving accuracy for radiologists in identifying pathologies. This makes it particularly useful for complex cases requiring precise anatomical visualization.
Is the uDR Aurora CX intended for single-use or reusable applications, and what does this mean for maintenance and infection control?
The uDR Aurora CX is supplied as a reusable medical system, meaning it is not designed for single-use. This allows for cost-effective deployment in clinical radiology departments, but it also requires adherence to strict cleaning, disinfection, and maintenance protocols to ensure patient safety and device longevity. The manufacturer’s guidelines should be followed to prevent cross-contamination and preserve imaging performance.
How does the MRI-safe parameter compliance of the uDR Aurora CX affect its placement in a radiology department?
The uDR Aurora CX is designed to operate within MRI-safe parameters for specified configurations, meaning it can be safely positioned in areas where MRI procedures are conducted, provided the manufacturer’s guidelines for electromagnetic compatibility are followed. This flexibility allows radiology departments to optimize space and workflow by co-locating X-ray and MRI systems without compromising patient safety.
What regulatory pathways has the uDR Aurora CX undergone, and how does this impact its adoption in clinical settings?
The uDR Aurora CX has been authorized through FDA 510(k) clearance and MDR compliance, confirming its adherence to stringent regulatory standards for X-ray imaging systems. This dual authorization supports its adoption in both U.S. and EU markets, ensuring clinicians can rely on its performance, safety, and compliance with global medical device regulations. The device is classified as Class II, reflecting its moderate risk profile.
What should clinicians consider when storing the uDR Aurora CX to maintain its performance and longevity?
While the device specifications do not detail storage conditions explicitly, reusable medical imaging systems like the uDR Aurora CX typically require protection from extreme temperatures, humidity, and physical damage. Clinicians should follow the manufacturer’s instructions for environmental storage, regular maintenance, and calibration to ensure consistent imaging quality and device reliability over time.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251167 | Class II | Active |
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Manufacturer
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
Sources (2)
- FDA 510(k) K251167 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026