# K040041: Nio 3MP Medical Grayscale Display System

- Pathway: 510(k) (Traditional)
- Applicant: Barco NV Barcoview
- Decided: Mar 29, 2004 after 80 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.
3 later devices descend from it; 2 cite it directly.
0 of 6 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)

## Most influential descendants
- K150821: MDNG-3220 (Nio 3MP LED) (2015), 1 descendant of its own
- K170944: LCD Monitor (MD310C, MD310G, MD210G) (2017), 0 descendants of its own
- K042661: Nio 3MP Medical Flat Panel Display System (2004), 0 descendants of its own

## Indications for use
The Nio 3MP 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/K040041
Methodology: https://510kreport.com/methodology