# K230520: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Mar 21, 2023 after 22 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). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133663: Nio Color 2MP, Barco N.V. (2014) Summary page 4.
- K170837: Nio Color 3MP (MDNC-3421), Barco N.V. (2017) Summary page 4.

## Most influential descendants
- K233693: Nio Color 8MP (MDNC-8132) (2023), 0 descendants of its own

## Indications for use
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display 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/K230520
Methodology: https://510kreport.com/methodology