# K082493: Medical Display, MD205MG-1

- Pathway: 510(k) (Traditional)
- Applicant: Nec Display Solutions, Ltd.
- Decided: Oct 23, 2008 after 55 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: 7 generations back to K913770 (1991). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063269: 5MP Medical Monochrome Reference Display, Model MDM2010-5NC, Chi Lin Technology Co., Ltd. (2007) Summary page 1.

## Indications for use
The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography by trained physicians. To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards. The MD205MG-1 cannot be used for a life-support system. This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

Source page: https://510kreport.com/device/K082493
Methodology: https://510kreport.com/methodology