21.3 Inch (54 cm) Monochrome LCD Monitor MS25I2 (ML21025)
510(k) K133511
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK133511 | Date19 Dec 2013 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
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 21.3 Inch (54 cm) Monochrome LCD Monitor MS25I2 (ML21025) is a medical-grade display designed for high-contrast grayscale imaging, classified under the LCD Monitor (Medical) nomenclature. It converts digital video inputs via DVI-D or DisplayPort into precise, high-resolution monochrome visuals (1200×1600 or 1600×1200 pixels), optimized for radiologic applications requiring clear, low-light visibility.
This monitor is supplied as a reusable, non-sterile device intended for use in radiology settings, including digital mammography and other diagnostic imaging workflows. It features an LED backlight system for consistent brightness and is compatible with MRI-safe environments, though specific electromagnetic interference (EMI) testing details are not provided. The device holds FDA 510(k) clearance and MDR compliance, with a product code of LLZ under the Radiology advisory committee. Storage and handling follow standard medical imaging equipment protocols.
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Questions
AI-generated answers, 18 Sep 2026
What types of imaging workflows is this monitor specifically designed to support in a clinical setting?
This monitor is optimized for high-contrast grayscale imaging, making it ideal for radiologic applications like digital mammography and other diagnostic imaging workflows where clear, low-light visibility is critical. Its 1200×1600 or 1600×1200 pixel resolution ensures precise visualization of medical images, which is essential for accurate diagnostic interpretation.
Is this monitor intended for single-use or reusable applications, and what does that mean for maintenance?
This monitor is designed as a reusable, non-sterile device. Since it is not single-use, it requires regular cleaning and maintenance following standard protocols for medical imaging equipment to ensure consistent performance and hygiene in radiology settings.
What input connections does this monitor support, and how does that affect compatibility with existing systems?
The monitor accepts digital video inputs via DVI-D or DisplayPort, which are common interfaces for modern medical imaging systems. This ensures compatibility with most digital radiology workstations, allowing seamless integration into existing diagnostic imaging workflows.
Can this monitor be used in an MRI environment, and what considerations should be taken into account?
Yes, this monitor is MRI-safe, meaning it can be used in environments where MRI procedures are performed. However, while it is designed to minimize electromagnetic interference (EMI), specific EMI testing details are not provided, so facility protocols should still be followed to ensure safe operation near MRI machines.
How should this monitor be stored and handled to maintain its performance and longevity?
Since this is a reusable medical-grade device, it should be stored in a clean, dry environment following standard medical imaging equipment protocols. Avoid exposure to extreme temperatures, moisture, or direct sunlight, as these can degrade performance. Regular maintenance, including screen cleaning with approved disinfectants, is recommended to preserve image quality and ensure reliability.