# K141428: MDMC-12133

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Jun 27, 2014 after 28 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
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K201777: 31HN713D (2020), 6 descendants of its own
- K223423: 32HQ713D (2023), 3 descendants of its own
- K230845: 32HL512D, 31HN713D, 32HQ713D (2023), 2 descendants of its own
- K232127: 21HQ513D, 32HL512D, 31HN713D, 32HQ713D (2023), 1 descendant of its own
- K221061: 21HQ613D (2022), 1 descendant of its own

## Indications for use
The MDMC-12133 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 especially designed for breast tomosynthesis applications.

Source page: https://510kreport.com/device/K141428
Methodology: https://510kreport.com/methodology