# K170476: Nio Color 5.8MP (MDNC-6121)

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Mar 28, 2017 after 40 days
- Product code: PGY (Display, Diagnostic Radiology)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K203106: Nio Fusion 12MP (MDNC-12130) (2020), 0 descendants of its own

## Indications for use
The MDNC-6121 is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Source page: https://510kreport.com/device/K170476
Methodology: https://510kreport.com/methodology