# K103792: Barco Mammo Tomosynthesis

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Mar 4, 2011 after 67 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.
32 later devices descend from it; 2 cite it directly.
0 of 33 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
- K151883: 5MP Monochrome LCD Monitor, RadiForce GX540 (2015), 30 descendants of its own
- K162497: 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR (2016), 14 descendants of its own
- K160326: 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) (2016), 12 descendants of its own
- K172738: RadiForce RX560, RX560-AR (2017), 11 descendants of its own
- K191137: 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 (2019), 6 descendants of its own

## Indications for use
The Barco Mammo Tomosynthesis (MIDMVG-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/K103792
Methodology: https://510kreport.com/methodology