# K063197: 21.3 Inch  (54CM) Monochrome LCD Monitor MDL2118A (ME355I2)

- Pathway: 510(k) (Traditional)
- Applicant: Totoku Electric Co., Ltd.
- Decided: Nov 30, 2006 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 MDL2118A (ME355i2) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.

Source page: https://510kreport.com/device/K063197
Methodology: https://510kreport.com/methodology