# K091274: Coronis 5MP HD, Model MDMG 5121

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Jul 14, 2009 after 75 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 Coronis 5MP HD (MDMG-5121) Display is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

Source page: https://510kreport.com/device/K091274
Methodology: https://510kreport.com/methodology