# K052352: Color Coronis 2MP-21 and MFCD 2321

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Sep 30, 2005 after 32 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: 2 generations back to K000294 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040365: Color Coronis 2MP Medical Flat Panel Display System, Barco N.V. (2004) Summary page 1.
- K040158: MFCD 2320, Barco N.V. (2004) Summary page 3.

## Most influential descendants
- K061018: Planar Dome EX Line Model Dome E2C (2006), 0 descendants of its own

## Indications for use
The Color Coronis 2MP-21" is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The MFCD 2321 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Source page: https://510kreport.com/device/K052352
Methodology: https://510kreport.com/methodology