# K083332: MD21M 21.3 Diagnostic Imaging LCD Monitor, Model L218TK

- Pathway: 510(k) (Traditional)
- Applicant: Nec Display Solutions, Ltd.
- Decided: Jan 9, 2009 after 58 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 K040982 (2004). 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)
- K063579: 2MP Medical Color Reference Display, Model MDC2130-2HC, Chi Lin Technology Co., Ltd. (2006) Summary page 1.

## Indications for use
The L218TK Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. TheL218TK cannot be used for a life-support system. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Source page: https://510kreport.com/device/K083332
Methodology: https://510kreport.com/methodology