# K133663: Nio Color 2MP

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Mar 25, 2014 after 116 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K230520: Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) (2023), 1 descendant of its own
- K233693: Nio Color 8MP (MDNC-8132) (2023), 0 descendants of its own
- K152030: Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) (2015), 0 descendants of its own

## Indications for use
The NIO 2MP LED Display (MDNC-2221) is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K133663
Methodology: https://510kreport.com/methodology