# K161229: Mammo Tomosynthesis (MDMG-5221)

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: May 18, 2016 after 16 days
- Product code: PGY (Display, Diagnostic Radiology)
- 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: 1 generation back to K090603 (2009). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K090603: Barco 5MP Mammo, Model MDMG-5221, Barco N.V. (2009) Summary page 4.

## Most influential descendants
- 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 Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Source page: https://510kreport.com/device/K161229
Methodology: https://510kreport.com/methodology