Re: Should I submit the entire copy of my software in a 510(k) submission??
FDA guidance states that "Software for most medical image management devices is considered to be of minor concern." (including processing, but without "techniques to identify abnormalities in medical images or assist in diagnosis")
From 2008, it seams that most image processing softwares, (with more and more sophisticate functions) are submitted in moderate loc.
Except for treatment planing system (x ray beams calculation), do you know other types of medical software submitted in major level of concern ?