# K150145: MD322C8 31.5 Diagnostic Imaging LCD Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nec Display Solutions, Ltd.
- Decided: Feb 6, 2015 after 15 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.
1 later device descends from it; 1 cites it directly.
0 of 11 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.

## Most influential descendants
- K162196: Dell UP3216Q with QUBYX PerfectLum bundle (2016), 0 descendants of its own

## Indications for use
The MD322C8 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. MD322C8 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 IEC60601-1-1 certified equipment.

Source page: https://510kreport.com/device/K150145
Methodology: https://510kreport.com/methodology
