Image courtesy of Eizo Inc.
September 3, 2015 — Eizo Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for breast tomosynthesis on its 5-megapixel monochrome medical monitor, the RadiForce GX540.
Digital breast tomosynthesis is a method of breast screening that allows the radiologist to view detailed three-dimensional images of the breast assembled from multiple X-ray pictures. When used in combination with digital mammography, tomosynthesis provides radiologists with multiple screening techniques that can be utilized together for increased diagnostic precision in breast cancer detection. The FDA 510(k) clearance for the RadiForce GX540 includes tomosynthesis, mammography, and general radiography.
The RadiForce GX540’s high resolution of 5 megapixels (2,048 x 2,560) LCD LED backlight with fast response time, which makes it ideal for viewing the fine details in breast images. To detect the smallest structures, the monitor offers a high contrast ratio of 1,200:1. The deeper black levels distinguish similar shades of gray for sharper monochrome image reproduction.
Eizo's RadiCS UX1 quality control tool performs precise calibration conforming to DICOM Part 14 and enables quality control complying with ACR Practice Guideline for digital mammography monitors.
For more information: www.eizo.com
October 24, 2025 
