# K090603: Barco 5MP Mammo, Model MDMG-5221

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Apr 22, 2009 after 48 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K161229: Mammo Tomosynthesis (MDMG-5221) (2016), 4 descendants of its own
- K190848: JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor (2019), 2 descendants of its own
- K231170: C350/C350G LCD Monitor; M550/M550G LCD Monitor (2023), 0 descendants of its own
- K230723: C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor (2023), 0 descendants of its own
- K212231: C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor (2022), 0 descendants of its own

## Indications for use
The Barco 5MP Mammo device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review and analysis by trained medical practitioners.

Source page: https://510kreport.com/device/K090603
Methodology: https://510kreport.com/methodology