# K041737: 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)

- Pathway: 510(k) (Special)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Jul 13, 2004 after 15 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: 5 generations back to K913770 (1991). 17 ancestors in all.
14 later devices descend from it; 1 cites 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)
- K033859: Barcoview MGD 521M Digital Mammography Display, Barco NV Barcoview (2004) Summary page 1.

## Most influential descendants
- K061447: 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2) (2006), 13 descendants of its own
- 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

## Indications for use
ME511L (MDL2105A) is intended for use with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography.

Source page: https://510kreport.com/device/K041737
Methodology: https://510kreport.com/methodology