# K040040: Nio 5MP 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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
- K042662: Nio 5MP Medical Flat Panel Display System (2004), 0 descendants of its own

## Indications for use
The Nio 5MP 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/K040040
Methodology: https://510kreport.com/methodology