NIO 5MP Medical Flat Panel Display System
by Barco NV Barcoview EUDAMED510(k)
Active
510(k) K042662
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK042662 | Date22 Nov 2004 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The NIO 5MP Medical Flat Panel Display System is a Medical Display Device (UDI Classification: LLZ) designed for high-resolution imaging in radiology applications. It features a 5-megapixel flat panel display optimized for medical imaging, providing clear visualization of diagnostic images such as X-rays, CT scans, and MRIs.
This system is intended for use in radiology departments and clinical imaging settings. Supplied as a reusable device, it requires proper storage and maintenance to ensure optimal performance and image fidelity. Authorized under FDA 510K and MDR, it adheres to regulatory standards for medical imaging displays, ensuring compatibility with MRI environments and compliance with sterility and safety protocols.
Other devices from Barco NV Barcoview
Questions
AI-generated answers, 18 Sep 2026
What types of medical imaging studies is the NIO 5MP Medical Flat Panel Display System designed to support in a clinical setting?
The NIO 5MP Medical Flat Panel Display System is specifically optimized for high-resolution visualization of diagnostic imaging modalities commonly used in radiology, including X-rays, CT scans, and MRIs. Its 5-megapixel display ensures clear and detailed image fidelity, making it suitable for interpreting complex radiographic studies in clinical imaging environments.
Is the NIO 5MP Medical Flat Panel Display System intended for single-use or reusable applications, and what maintenance is required?
The NIO 5MP Medical Flat Panel Display System is designed as a reusable device. To maintain optimal performance and image quality, it requires proper storage and regular maintenance as outlined in the manufacturer’s guidelines. Since it is not sterile by design, it should not be used in procedures requiring sterile conditions.
How does the NIO 5MP Medical Flat Panel Display System ensure compatibility with MRI environments, and what regulatory standards does it meet?
The NIO 5MP Medical Flat Panel Display System is explicitly designed to be MRI-compatible, allowing it to be used safely in radiology departments where MRI scans are performed. It adheres to regulatory standards including FDA 510K clearance and MDR (Medical Device Regulation) compliance, ensuring it meets safety and performance requirements for medical imaging applications.
What are the key specifications that make the NIO 5MP Medical Flat Panel Display System suitable for radiology departments?
The system’s 5-megapixel resolution provides high-definition imaging, which is critical for interpreting detailed radiographic studies like X-rays, CT scans, and MRIs. Its classification as a Medical Display Device (UDI: LLZ) under the FDA’s radiology category further confirms its suitability for clinical imaging workflows, ensuring compatibility with standard radiology equipment and protocols.