# K062621: Nio 5MP-21 and MDNG-5121 CB

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Mar 19, 2007 after 195 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: 6 generations back to K001753 (2000). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042221: Coronis 5MP Medical Flat Panel Display System, Barco NV Barcoview (2004) Summary page 1.

## Most influential descendants
- K132610: 5MP Grayscale LCD Display (2013), 0 descendants of its own

## Indications for use
The Nio 5MP-21" is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board BarcoMed Nio, will be marketed as separate device.

Source page: https://510kreport.com/device/K062621
Methodology: https://510kreport.com/methodology