# K111496: 21.3 Inch (54CM) Monochrome Digital Mammography LCD Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Sep 26, 2011 after 118 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: 7 generations back to K913770 (1991). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061447: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2), Totoku Electric Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K131137: 21.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5) (2013), 1 descendant of its own
- K151007: 21.3 inch (54 cm) Color Digital Mammography LCD Monitor CCL550i2(CL21550) (2015), 0 descendants of its own

## Indications for use
21.3 inch (54cm) Monochrome Digital Mammography SM pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently, MS53i2 (ML21053) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

Source page: https://510kreport.com/device/K111496
Methodology: https://510kreport.com/methodology