# K113443: 21.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Dec 23, 2011 after 32 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: 9 generations back to K913770 (1991). 27 ancestors in all.
2 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)
- K081945: 21.3-Inch (54CM) Monochrome LCD Monitor MS21I2 (MDL2127A), Totoku Electric Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- 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 (54 cm) Monochrome 2M pixel LCD Monitor MS2312 (ML21023) 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/K113443
Methodology: https://510kreport.com/methodology