# K171812: Nio Color 2MP (MDNC-2123)

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Jul 19, 2017 after 30 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: 2 generations back to K131295 (2013). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170837: Nio Color 3MP (MDNC-3421), Barco N.V. (2017) Summary page 4.

## Indications for use
The Nio Color 2MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display may be used in dental applications.

Source page: https://510kreport.com/device/K171812
Methodology: https://510kreport.com/methodology