Identifiers
- 510(k) Number
- K140108 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The 3MP Color LCD Display is a radiology-grade monitor classified under product code LLZ, designed for high-resolution medical imaging. It provides a 3-megapixel color LCD interface for clear visualization of diagnostic images, supporting applications in radiology and human-machine interaction within clinical settings.
This device is supplied as a reusable medical display, intended for integration into imaging systems where color fidelity and contrast are critical. It is not single-use and requires proper storage in a clean, dry environment to maintain performance. The device holds FDA 510(k) clearance and MDR authorization, adhering to regulatory standards for radiology equipment. No MRI safety classification or sterility requirements are specified.
Frequently asked questions
What types of medical imaging systems can this display be integrated into, and why is color fidelity important in these settings?
This 3MP Color LCD Display is designed for integration into radiology imaging systems where high-resolution visualization is critical, such as X-ray, CT, or ultrasound workstations. Color fidelity ensures accurate differentiation of tissue densities, contrast resolution, and subtle image details—essential for diagnostic precision in interpreting medical images like mammograms, angiograms, or soft-tissue scans. The radiology-grade classification (product code LLZ) confirms its suitability for clinical environments where image accuracy directly impacts patient care.
How should I store this display to ensure it remains functional and clean between uses?
Since this is a reusable device, store it in a clean, dry environment away from direct sunlight, moisture, or dust to prevent performance degradation. Avoid extreme temperatures or humidity, as these can affect display clarity or calibration. Regular cleaning with appropriate medical-grade wipes (if manufacturer guidelines permit) will maintain hygiene, though no sterility requirements are specified for this device.
Is this display compatible with MRI environments, or are there any safety considerations I should know?
The specifications do not mention MRI safety classification, meaning this display is not certified for use in MRI suites. If integrating into an MRI-compatible system, verify compatibility with the imaging equipment’s electromagnetic interference (EMI) standards, as unshielded displays could interfere with MRI operations or pose safety risks to patients. Always consult the manufacturer’s installation guidelines for specific environments.
What does the FDA 510(k) clearance and MDR authorization mean for this product’s reliability?
The FDA 510(k) clearance and MDR authorization indicate that this display has undergone regulatory review to demonstrate substantial equivalence to legally marketed predecessors (per the SESE decision code) and compliance with EU medical device regulations. This suggests it meets established safety and performance standards for radiology-grade displays, though actual clinical use should align with the manufacturer’s instructions and local healthcare protocols.
Are there different sizes or models available for this display, or is it a single configuration?
The provided data does not specify multiple sizes or models for the 3MP Color LCD Display, implying it is offered as a single, standardized configuration with a 3-megapixel resolution. For exact dimensions or customization options, refer to the manufacturer’s technical documentation or contact Shenzhen Beacon Display Technology Co., Ltd. directly, as specifications like screen size (e.g., diagonal inches) are not detailed in the regulatory submission.
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: Products &Solutions - Beacon Display, Shenzhen Beacon Display Technology Co., Ltd., Shenzhen Beacon Display 3MP Color LCD Monitors C32s+…, Beacon C316S 3MP Color Radiology Monitor Sales | Hiliex, 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S ...
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 | K140108 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Beacon Display Technology Co., Ltd.
Sources (2)
- FDA 510(k) K140108 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026