# K052403: Coronis 2MP-21 and MFGD 2621

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Sep 15, 2005 after 14 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 K001753 (2000). 4 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023322: Coronis 2MP Medical Flat Panel Display System, Barco N.V. (2002) Summary page 1.
- K033004: MFGD 2320 20 Inch 2 Megapixel Greyscale LCD Display, Barco NV Barcoview (2004) Summary page 3.

## Most influential descendants
- K061927: Coronis Color 3MP and MDCC 3120-DL (2006), 1 descendant of its own
- K080320: Primevue 21 3MP Color Display, Model AC-QX21-A9300 (2008), 0 descendants of its own
- K061924: Coronis 3MP and MDCG 3120-CB (2006), 0 descendants of its own
- K061928: Coronis Color 2MP and MDCC 2121 (2006), 0 descendants of its own
- K061926: Coronis 2MP and MDCG 2121 - CB (2006), 0 descendants of its own

## Indications for use
The 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 MFGD 2621 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/K052403
Methodology: https://510kreport.com/methodology