# K242008: Coronis OneLook

- Pathway: 510(k) (Special)
- Applicant: Barco N.V.
- Decided: Aug 2, 2024 after 23 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 K151505 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151505: Coronis Uniti, Barco N.V. (2015) Summary page 5.

## Indications for use
The display is intended to be used in displaying and viewing digital images, including standard and multiframe 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 gynaecological US.

Source page: https://510kreport.com/device/K242008
Methodology: https://510kreport.com/methodology