# K061928: Coronis Color 2MP and MDCC 2121

- Pathway: 510(k) (Traditional)
- Applicant: Barcoview
- Decided: Sep 5, 2006 after 60 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: 5 generations back to K001753 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052403: Coronis 2MP-21 and MFGD 2621, Barcoview (2005) Summary page 1.

## Indications for use
The MDCC 2121 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/K061928
Methodology: https://510kreport.com/methodology