# K131137: 21.3 Inch Monochrome Digital Mammography LCD Monitor MS55I2 (ML21055, MD211G5)

- Pathway: 510(k) (Traditional)
- Applicant: Jvckenwood Corporation
- Decided: Jul 18, 2013 after 86 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: 8 generations back to K913770 (1991). 20 ancestors in all.
1 later device descends 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)
- K111496: 21.3 Inch (54CM) Monochrome Digital Mammography LCD Monitor, Totoku Electric Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- 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 Monochrome Digital Mammography SM pixel LCD Monitor with sub-pixel driving techniques enabling 15M subpixels to be driven independently. MS55i2 (ML-21055, MD21I 1G5) 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/K131137
Methodology: https://510kreport.com/methodology