# K081945: 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A)

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Sep 12, 2008 after 66 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: 8 generations back to K913770 (1991). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063198: 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2), Totoku Electric Co., Ltd. (2006) Summary page 1.
- K081242: 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A), Tokotu Electric Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- 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 with sub-pixel driving techniques enabling 6M subpixels to be driven independently, MS21i2 (MDL2127A) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

Source page: https://510kreport.com/device/K081945
Methodology: https://510kreport.com/methodology