FullFocus

FullFocus is a web-based software viewer for managing and displaying digital pathology images (whole slide images) from FFPE tissue slides scanned by FDA-cleared scanners. It enables pathologists to review, zoom, pan, annotate, and measure images to aid in primary diagnosis. The device is not intended for frozen sections, cytology, or non-FFPE hematopathology specimens.

FullFocus is a browser-based software application (not a scanner) that displays images in DICOM, SVS, and NDPI formats from specified Leica and Hamamatsu scanners on specified Dell and JVC-Kenwood displays. It runs on Windows or macOS with minimum 4GB RAM and requires 10 Mbps network bandwidth. Unlike the predicate devices, FullFocus stores images in cloud storage rather than end-user local network storage.

Not stated in this summary.

FullFocus is substantially equivalent because it performs the identical intended function as the predicate devices—viewing and interpreting FFPE tissue slide images for primary diagnosis—using the same image file formats, image manipulation functions (zoom, pan, annotate, measure), and display hardware. Pixel-wise comparison testing demonstrated images reproduced by FullFocus are identical to those from predicate viewers (95th percentile color difference <3 CIEDE2000), and measurement accuracy testing confirmed performance equivalent to predicates. The primary difference—cloud versus local storage—does not affect the diagnostic capability or safety/effectiveness of image display to pathologists.