# K020059: MFCD 118I

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Apr 3, 2002 after 85 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
Longest line of descent: 1 generation back to K000291 (2000). 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)
- K000291: MFCD 118, Barco N.V. (2000) Summary page 1.

## Indications for use
The MFCD 118i Medical Flat Color Display is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners. The device is suitable for use in the MRI environment.

Source page: https://510kreport.com/device/K020059
Methodology: https://510kreport.com/methodology