# K112145: Monochrome Digital Mammography LCD Monitor MS33I2

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Nov 7, 2011 after 104 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). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090947: 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model  MS3112 (MDL2128A), Totoku Electric Co., Ltd. (2010) Summary page 1.

## Most influential descendants
- K133686: 21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035) (2014), 1 descendant of its own
- K200161: 3MP Monochrome Digital Mammography LCD Monitor MS-S300 (2020), 0 descendants of its own

## Indications for use
20.8 inch Monochrome Digital Mammography 3M pixel LCD Monitor with sub-pixel driving techniques enabling 9M subpixels to be driven independently, MS3312 (ML21033) 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/K112145
Methodology: https://510kreport.com/methodology