# K203106: Nio Fusion 12MP (MDNC-12130)

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Nov 10, 2020 after 26 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
Longest line of descent: 1 generation back to K170476 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170476: Nio Color 5.8MP (MDNC-6121), Barco N.V. (2017) Summary page 4.

## Indications for use
The display is intended to be used in displaying and viewing digital images, including standard and multiframe 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/K203106
Methodology: https://510kreport.com/methodology