# K090732: Nio Color 3MP and MDNC-3121

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Apr 20, 2009 after 32 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The MDNC-3121 Medical Flat Panel Display System 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. The MDNC-3121, which is part of the Nio Color 3MP system, will be marketed separately.

Source page: https://510kreport.com/device/K090732
Methodology: https://510kreport.com/methodology