I don&#x27;t know if you have an organization around you or not, but be careful. If your software is actually producing some sort of a quantitative or even qualititative &quot;you have this visual defect or not&quot; then the FDA may very well consider you a Medical Device and you&#x27;ll have to go through submission, etc.<p>There are a lot of small businesses out there that are unwittingly (and illegally) producing medical devices and don&#x27;t even know it (yet!).