# K040039: Nio 2MP Medical Grayscale Display System

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Mar 17, 2004 after 68 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: 2 generations back to K001753 (2000). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013922: Coronis 3MP Medicl Flat Panel Display System, Barco N.V. (2002) Summary page 1.

## Most influential descendants
- K042660: Nio 2MP Medical Flat Panel Display System (2004), 8 descendants of its own
- K052958: Color Nio 2MP, E-2320 C (2005), 2 descendants of its own
- K052276: Nio 2MP-20 and E-2620 S (2005), 1 descendant of its own
- K070726: Nio Color 3MP and MDNC 3120 (2007), 0 descendants of its own
- K062905: Nio Fusion 4MP; MDNC 4130 (2006), 0 descendants of its own

## Indications for use
The Nio 2MP Medical Grayscale Display System is intended to be used as a tool in displaying and viewing digital Images (excluding digital mammography) for review and analysis by trained medical practitioners.

Source page: https://510kreport.com/device/K040039
Methodology: https://510kreport.com/methodology