# K061947: 21.3 Inch Monochrome LCD Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nec Display Solutions, Ltd.
- Decided: Jul 25, 2006 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K001753 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023322: Coronis 2MP Medical Flat Panel Display System, Barco N.V. (2002) Summary page 2.

## Indications for use
The 21.3inch Monochrome LCD Monitor is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. The 21.3inch Monochrome LCD Monitor must not be used for primary diagnostic in mammography.

Source page: https://510kreport.com/device/K061947
Methodology: https://510kreport.com/methodology