# K181609: RadiForce GX560, GX560-AR

- Pathway: 510(k) (Abbreviated)
- Applicant: Eizo Corporation
- Decided: Aug 24, 2018 after 66 days
- Product code: PGY (Display, Diagnostic Radiology)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K103792 (2011). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162497: 5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR, Eizo Corporation (2016) Summary page 4.

## Most influential descendants
- K252030: RadiForce GX570; RadiForce GX570-AR (2025), 0 descendants of its own

## Recalls of this device
- Jul 30, 2019 · Class II · Z-2293-2020: Under certain conditions, a marble pattern infrequently appears on the monitor.

## Indications for use
This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Source page: https://510kreport.com/device/K181609
Methodology: https://510kreport.com/methodology