# K052199: 21.3-Inch (54 CM) Monochrome LCD Monitor MDL2115A (ME353I), (DV3MM-HB), (ME353IM)

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Sep 22, 2005 after 41 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: 2 generations back to K030274 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050485: 20.8-Inch (53CM) Monochrome LCD Monitor MDL2110A (ME351I), (DV3MM-HB), Totoku Electric Co., Ltd. (2005) Summary page 1.

## Indications for use
21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Source page: https://510kreport.com/device/K052199
Methodology: https://510kreport.com/methodology