Nio Color 8MP (MDNC-8132)

510(k) Number

K233693 ↗

FDA Product Code

PGY

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Imagedesk

  Class II

  FDA 510(k) K020061 Active Cleared 3 Apr 2002

• Barco Mammo Tomosynthesis

  Class II

  FDA 510(k) K103792 Active Cleared 4 Mar 2011

• Nio Color 3MP and Mdnc-3121

  Class II

  FDA 510(k) K090732 Active Cleared 20 Apr 2009

• Coronis Fusion 4MP LED Display

  Class II

  FDA 510(k) K143157 Active Cleared 12 Nov 2014

• Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)

  Class II

  FDA 510(k) K191845 Active Cleared 6 Sep 2019

• LCD Monitor (MDEC-2523)

  Class II

  FDA 510(k) K243307 Active Cleared 13 Dec 2024

See all devices from Barco N.V. →

• What types of medical images can the Nio Color 8MP (MDNC-8132) display clearly, and where is it typically used in a clinical setting?

  The Nio Color 8MP (MDNC-8132) is designed for high-resolution visualization of radiographic and fluoroscopic images, as well as other diagnostic imaging modalities. It is specifically intended for use in radiology departments and imaging suites, where clinicians interpret detailed medical images for diagnostic purposes.

• Is the Nio Color 8MP (MDNC-8132) a single-use or reusable device, and what does this mean for maintenance and cleaning?

  The Nio Color 8MP (MDNC-8132) is supplied as a reusable medical device. This means it is built for repeated use in clinical settings, and proper cleaning, maintenance, and storage as outlined by the manufacturer are essential to ensure its performance, longevity, and compliance with regulatory standards.

• What regulatory pathways has the Nio Color 8MP (MDNC-8132) followed, and what does this indicate about its compliance?

  The Nio Color 8MP (MDNC-8132) has undergone FDA 510(k) clearance and EU MDR compliance, confirming it meets the necessary regulatory requirements for diagnostic radiology displays in both the United States and the European Union. These pathways ensure the device adheres to safety, performance, and quality standards.

• Can the Nio Color 8MP (MDNC-8132) be used in an MRI environment, and if not, what precautions should be taken?

  The Nio Color 8MP (MDNC-8132) is explicitly intended for use in non-MRI environments. Since MRI environments involve strong magnetic fields, electromagnetic interference, or potential hazards from metallic components, this device should not be placed in such settings. Always follow manufacturer guidelines for proper placement and usage.

• How do I verify the compatibility of this display with my existing imaging systems before purchasing?

  The Nio Color 8MP (MDNC-8132) is classified as a diagnostic radiology display and supports high-resolution imaging for modalities like radiography and fluoroscopy. To ensure compatibility, consult the manufacturer’s documentation or contact Barco N.V. for technical specifications on connectivity (e.g., DICOM, HDMI, or other interfaces) and system requirements. Confirming your current imaging system’s output standards will help determine seamless integration.