RadiForce MX317W-PA

The RadiForce MX317W-PA is a 30.5-inch color LCD monitor intended for in vitro diagnostic use to display digital histopathology images acquired from whole-slide imaging scanners and viewed with validated digital pathology software. It serves as an aid to pathologists for primary diagnosis review and interpretation of formalin-fixed, paraffin-embedded (FFPE) histopathology specimens, excluding frozen sections, cytology, and non-FFPE hematopathology samples.

The proposed device features a 4,096 × 2,160 pixel (8MP) IPS LCD panel with 0.1674 mm pixel pitch and 60 Hz frame rate, compared to the predicate's 27-inch display with 0.155 mm pixel pitch and 120 Hz refresh rate. The MX317W-PA includes USB Type-C DisplayPort Alt Mode, dual DisplayPort, and HDMI inputs with daisy-chain output capability, integrated optical sensor with RadiCS calibration software, and true 10-bit color with 3-bit FRC dithering. Both use LED backlighting and RGB vertical stripe subpixel patterns.

Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices (April 20, 2016) and AAPM On-line Report No. 03:2005 for quality-control testing procedures.

The MX317W-PA is substantially equivalent because it has the same stated intended use for displaying IVD-labeled histopathology images for primary diagnosis as the predicate MDPC-8127. Comprehensive bench testing (spatial resolution, pixel defects, luminance, grayscale, color gamut, etc.) demonstrated equivalent display characteristics despite minor technological differences in screen size, frame rate, pixel pitch, and interface options—differences determined not to affect safety or effectiveness. The larger screen and integrated sensor actually enhance the clinical workflow without changing the fundamental diagnostic purpose or risk profile.