# K131295: Nio Color 3MP Led

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: May 29, 2013 after 23 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.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K170837: Nio Color 3MP (MDNC-3421) (2017), 4 descendants of its own
- 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
- K191705: OptikView GUP2103CMI (2020), 0 descendants of its own
- K171812: Nio Color 2MP (MDNC-2123) (2017), 0 descendants of its own

## Indications for use
The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Source page: https://510kreport.com/device/K131295
Methodology: https://510kreport.com/methodology