# K040695: 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Jun 7, 2004 after 82 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 K000293 (2000). 3 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021738: Flat Panel Displays, ME Series & CCL Series, Totoku Electric Co., Ltd. (2002) Summary page 1.

## Most influential descendants
- K050617: 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HB (2005), 6 descendants of its own
- K063198: 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2) (2006), 5 descendants of its own
- K081945: 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A) (2008), 3 descendants of its own
- K113443: 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023) (2011), 2 descendants of its own
- K133511: 21.3 Inch (54 CM) Monochrome LCD Monitor MS25I2(ML21025) (2013), 1 descendant of its own

## Indications for use
21.3-inch (54cm) Monochrome LCD Monitor ME213L (MDL2108A) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Source page: https://510kreport.com/device/K040695
Methodology: https://510kreport.com/methodology