# K052429: Coronis 3MP-21 and MFGD 3621

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Sep 15, 2005 after 9 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013922: Coronis 3MP Medicl 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.

## Indications for use
The Coronis 3MP-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 3621 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/K052429
Methodology: https://510kreport.com/methodology