# K111989: Coronis Fusion 4MP DL

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Sep 22, 2011 after 71 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K143157: Coronis Fusion 4MP LED (2014), 0 descendants of its own

## Indications for use
The Coronis Fusion 4MP DL (MDCC-4130) is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K111989
Methodology: https://510kreport.com/methodology