21.3 Inch Monochrome LCD Monitor
by Nec Display Solutions, Ltd.
510(k) K061947
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061947 | Date25 Jul 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- 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
Overview
AI-generated summary, 1 Oct 2026
This device is a 21.3 inch monochrome LCD monitor. It is a Class II X-ray system intended for use in medical imaging applications.
The device is supplied as a reusable monitor and has received FDA 510(k) clearance under K061947. It is manufactured by Nec Display Solutions, Ltd. and is authorized for use in radiology settings.
Other devices from Nec Display Solutions, Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the 21.3 inch monochrome LCD monitor used for?
This device is intended for use in medical imaging applications as part of an X-ray system, specifically designed for displaying radiographic images in radiology settings where grayscale precision is required for diagnostic interpretation.
Is the 21.3 inch monochrome LCD monitor reusable or single-use?
The monitor is supplied as a reusable device, meaning it is designed for repeated use over time after proper cleaning and maintenance, consistent with its classification as a durable medical imaging display rather than a disposable component.
What regulatory clearance does the 21.3 inch monochrome LCD monitor have?
The device has received FDA 510(k) clearance under submission number K061947, indicating it was found substantially equivalent to a legally marketed predicate device, which allows it to be legally marketed in the United States for its intended use.