That ship has sailed. They’ve made up their mind that this is a Class III, which is why most people are going to Europe with this technology, not the U.S.

College of American Pathologists - Regulators scanning the digital scanners

Keep in mind, this technology is completely fine for use now, and the FDA will regulate the whole workflow intact, killing any healthy vendor ecosystem…

I wish people realized we currently have the worst of both socialized and private healthcare.