# K050617: 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HB

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Apr 22, 2005 after 43 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: 4 generations back to K000293 (2000). 4 ancestors in all.
6 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)
- K040695: 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A), Totoku Electric Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- 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
- K210345: 2MP Monochrome LCD Monitor MS-S200 (2021), 0 descendants of its own

## Indications for use
21.3-inch (54cm) Monochrome LCD Monitor MDL2109A (ME251i) (DV2MM-HB) 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/K050617
Methodology: https://510kreport.com/methodology