MD211C3 21.3 Diagnostic Imaging LCD Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K130770 ↗

FDA Product Code

LLZ

FDA applicant

Nec Display Solutions , Ltd.

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• MD242C2 24 Diagnostic Imaging LCD Monitor

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• Medical Display, MD205MG-1

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• MD21M 21.3 Diagnostic Imaging LCD Monitor, Model L218TK

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See all devices from Nec Display Solutions, Ltd. →

• What is the primary purpose of the MD211C3 monitor in a radiology setting?

  The MD211C3 is specifically designed for diagnostic imaging in radiology departments. Its 3MP resolution and DICOM-calibrated luminance ensure accurate visualization of medical images, which is critical for diagnostic accuracy. The LED-backlit panel enhances clarity, making it ideal for interpreting X-rays, CT scans, and other imaging studies.

• Is this monitor intended for single-use or reusable applications, and how does that affect its maintenance?

  The MD211C3 is a reusable, non-sterile device, meaning it is built for repeated use in radiology environments. Since it is not sterile, it does not require sterilization between uses but should be cleaned regularly according to facility protocols to maintain hygiene and performance. Its durable design and factory calibration also help ensure consistent diagnostic quality over time.

• What energy-saving features does the MD211C3 include, and how do they benefit the user?

  The monitor includes a human sensor that automatically reduces power consumption when no one is present, helping to lower energy costs. This feature is particularly useful in radiology departments where monitors may remain on for extended periods but are often unoccupied, as it balances operational efficiency with energy savings.

• What display specifications make this monitor suitable for medical imaging, and how do they differ from standard monitors?

  The MD211C3 features a 21.3-inch display with 3MP resolution, which provides high pixel density for sharp, detailed images—essential for identifying subtle features in medical scans. Unlike consumer monitors, it is factory-calibrated to DICOM standards for luminance, ensuring consistent brightness and color accuracy across diagnostic displays. This calibration is critical for radiologists to avoid misinterpretation due to display variations.

• How is the regulatory approval process reflected in the device’s specifications, and what does it imply for users?

  The MD211C3 holds FDA 510(k) clearance (K130770) under the *Radiology* advisory committee, classified as *Substantially Equivalent* to a predicate device. This implies that its design and performance meet established safety and effectiveness standards for diagnostic imaging monitors. Users can rely on this approval as evidence that the device adheres to regulatory requirements for medical-grade displays, though they should still follow manufacturer guidelines for proper use and maintenance.