RadiForce GX570; RadiForce GX570-AR

The RadiForce GX570 and GX570-AR are monochrome LCD monitors (21.3-inch, 5MP resolution) designed for viewing and analyzing clinical radiological images, including mammography and digital breast tomosynthesis. They are intended for use by trained medical practitioners for diagnostic review and analysis.

The GX570 uses an IPS TFT LCD panel with 2,048 × 2,560 pixels (0.165 mm pitch) and LED backlight, matching the predicate GX560. Key differences include improved pixel aperture ratio (0.602 vs 0.541), support for 4-bit and 3-bit FRC dithering modes (vs 4-bit only), variable video bandwidth (25–290 MHz vs fixed 290 MHz), and repositioned ambient light sensor in the upper right bezel. Surface treatment options are Anti-Glare (GX570) or Anti-Reflection (GX570-AR).

Testing followed FDA's 'Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology' (September 28, 2022) and AAPM Task Group 18 (TG18) guidelines. Tests measured spatial resolution (MTF), pixel defects, temporal response, luminance, DICOM GSDF conformance, angular luminance dependency, luminance and chromaticity uniformity, noise power spectrum, display reflections, and small-spot contrast ratio.

The intended use and indications are substantially identical. Although pixel aperture ratio, dithering capabilities, and sensor positioning differ, bench testing demonstrated the GX570 achieves display characteristics equivalent to the predicate GX560 and GX540. All measured performance parameters met pre-defined criteria, confirming these technological differences do not affect safety or effectiveness for diagnostic image review.