# K130772: MD211C2 21.3 Diagnostic Imaging LCD Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nec Display Solutions, Ltd.
- Decided: Apr 18, 2013 after 29 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: 4 generations back to K040982 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083907: MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TG, Nec Display Solutions, Ltd. (2009) Summary page 1.

## Indications for use
The MD21I1C2 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers. MD21 I C2 cannot be used for a life-support system. This device must not be used in digital mammograpl4. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

Source page: https://510kreport.com/device/K130772
Methodology: https://510kreport.com/methodology