5MP Grayscale LCD Display
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K132610 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)
This device is a 5MP Grayscale LCD Display, classified under the product code LLZ in the FDA’s nomenclature. It is a high-resolution liquid crystal display designed for medical imaging applications, providing clear visual output for diagnostic radiology workflows.
The 5MP Grayscale LCD Display is intended for use in radiology settings, where its 5-megapixel resolution and grayscale imaging capabilities support accurate interpretation of medical images. Supplied as a standalone unit, it requires no sterilization and is intended for reusable clinical environments. The device holds FDA 510(k) clearance under the Radiology Advisory Committee and complies with MDR requirements.
Frequently asked questions
What types of medical imaging workflows is this display designed to support in a radiology setting?
This 5MP Grayscale LCD Display is specifically engineered for diagnostic radiology workflows, where high-resolution grayscale imaging is critical. Its 5-megapixel resolution ensures clear visualization of medical images, aiding radiologists in accurately interpreting X-rays, CT scans, MRIs, and other diagnostic imaging modalities. The device’s design prioritizes clarity and detail, making it suitable for environments where precise image assessment is essential.
Is this display meant for single-use or reusable clinical environments, and how should it be maintained?
The 5MP Grayscale LCD Display is intended for reusable clinical environments and does not require sterilization. Since it is a standalone unit, maintenance should focus on regular cleaning with appropriate disinfectants suitable for medical-grade displays to prevent contamination and ensure longevity. The manufacturer’s guidelines should be followed for proper care and upkeep.
What regulatory pathways has this display undergone, and which advisory committee was involved in its clearance?
This display received FDA clearance through a traditional 510(k) pathway, classified under product code LLZ. The clearance was granted by the Radiology Advisory Committee (RA) and is marked as substantially equivalent (SESE). Additionally, it complies with the Medical Device Regulation (MDR) requirements, ensuring it meets both U.S. and European regulatory standards.
Does this display come with any specific accessories or is it a standalone unit?
The 5MP Grayscale LCD Display is supplied as a standalone unit, meaning it does not include bundled accessories like cables or mounts as part of the core product. However, it is designed to integrate into existing radiology workflows, so compatibility with standard medical imaging infrastructure (e.g., PACS systems) would depend on the user’s setup and the manufacturer’s compatibility specifications.
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 | K132610 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Beacon Display Technology Co., Ltd.
Sources (2)
- FDA 510(k) K132610 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026