# K161057: Diagnostic Imaging Color LCD Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nec Display Solutions, Ltd.
- Decided: May 13, 2016 after 29 days
- Product code: PGY (Display, Diagnostic Radiology)
- 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: 9 generations back to K000293 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142951: MD210C3 21.3 Diagnostic Imaging LCD Monitor, Nec Display Solutions, Ltd. (2014) Summary page 4.

## Indications for use
The MDC212C2 Color displays are 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 in conjunction with NEC approved display controllers. MDC212C2 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 IEC 60601-1-1 certified equipment.

Source page: https://510kreport.com/device/K161057
Methodology: https://510kreport.com/methodology