# K151505: Coronis Uniti

- Pathway: 510(k) (Traditional)
- Applicant: Barco N.V.
- Decided: Jul 17, 2015 after 43 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K242008: Coronis OneLook (2024), 0 descendants 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 (3D mammography) applications, breast MRI, and breast US. It is especially designed for CT and ultrasound including vascular and gynecological US.

Source page: https://510kreport.com/device/K151505
Methodology: https://510kreport.com/methodology