# K093197: Coronis Fusion 10MP, Model MDCG-10130

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Jun 23, 2010 after 257 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K132770: DOME S10 (2014), 0 descendants of its own
- K103724: 10 MP Grayscale Flat Panel Display (GX 1030) (2011), 0 descendants of its own

## Indications for use
The Coronis Fusion IOMP (MDCG-10130) is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.

Source page: https://510kreport.com/device/K093197
Methodology: https://510kreport.com/methodology