# K191845: Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Sep 6, 2019 after 58 days
- Product code: PGY (Display, Diagnostic Radiology)
- 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
Longest line of descent: 1 generation back to K130103 (2013). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130103: Coronis Fusion 6MP, Barco N.V. (2013) Summary page 6.

## Indications for use
The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The display is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. The Intuitive Workflow Tools are intended to be used as accessories for image enhancement in diagnostic displays.

Source page: https://510kreport.com/device/K191845
Methodology: https://510kreport.com/methodology