Whole slide imaging digitizes a full slide at diagnostic resolution, producing files that can reach several gigabytes. FDA authorization of WSI for primary diagnosis was the step that made digital pathology clinically viable.

Where This Gets Misread

This is the dependency that explains why the FDA device list contains hundreds of radiology entries and a handful of pathology ones. Radiology has been digital for thirty years. Most pathology laboratories still cut glass, and a model cannot analyze an image that was never created.