# K020058: Medical LE

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Apr 4, 2002 after 86 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: 4 generations back to K913770 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982690: Barco Medical Display Conformity and Consistency Software, Barco N.V. (1998) Summary page 1.

## Indications for use
The MediCal LE device is intended to be used as a tool for trained medical practitioners to calibrate and perform QA checks on color displays in home offices and hospitals.

Source page: https://510kreport.com/device/K020058
Methodology: https://510kreport.com/methodology