# K122843: MD211G3 21.3 Diagnostic Imaging LCD Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Prodigy Technology Consultant Co., Ltd.
- Decided: Oct 5, 2012 after 18 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 K000293 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090215: MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TL, Nec Display Solutions, Ltd. (2009) Summary page 1.

## Indications for use
The MD21103 gray scale 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. MD21I 03 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC6060 1-1-1 certified equipment.

Source page: https://510kreport.com/device/K122843
Methodology: https://510kreport.com/methodology