# K061447: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Jul 21, 2006 after 57 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: 6 generations back to K913770 (1991). 18 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041737: 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A), Totoku Electric Co., Ltd. (2004) Summary page 1.

## Most influential descendants
- K081242: 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A) (2008), 4 descendants of its own
- K071794: 15M Monochrome Digital Mammography LCD Monitor MDL2123A (MS51I2) (2008), 4 descendants of its own
- K090947: 21.3 (54 CM) Monochrome Digital Mammography LCD Monitor, Model  MS3112 (MDL2128A) (2010), 3 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

## Indications for use
5M Monochrome Digital Mammography LCD Monitor MDL2116A (MES51i2) 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/K061447
Methodology: https://510kreport.com/methodology