Best of luck with that. As someone who has taken medical imaging software through both, my preference would be to get CE marking first and allow the market and

Best of luck with that. As someone who has taken medical imaging software through both, my preference would be to get CE marking first and allow the market and the device to become establish before going for a 510K. The FDA predicate device process together with the glacial speed of the agency means making modifications to a system is unnecessarily difficult which is something you will need to do when innovating in a market. I find the CE process to be a more pragmatic approach. On some of the darker days with the FDA - and despite their 90 day target we had over 900 days between submission and final clearance - I found it helped to remember the famous Churchill quote; "When you are going through hell, keep going."