# K062131: Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Nov 17, 2006 after 114 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.
2 later devices descend from it; 2 cite it directly.
0 of 10 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
- K160347: Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 (2016), 0 descendants of its own
- K081357: 5MP Grayscale Flat Panel Display, Model, 6GF6201-5C$2# (Where $ = a-Z and # = 0-9) (2008), 0 descendants of its own

## Indications for use
The MDNG-5121 BB is intended to be used in displaying and viewing digital images, including digital mammography, for review and analasys by trained medical practitioners.

Source page: https://510kreport.com/device/K062131
Methodology: https://510kreport.com/methodology