2020 The Year Of RAP, page-1112

Yes, and hopefully they can even manage an abbreviated 510k which is a pathway you would use for a major update or feature rather than a new product. For a new product they would be doing a 510k where their own ResAppDx is the predicate device and they are demonstrating that the new product is substantially equivalent. This is a shoe in but still a lot of paperwork compared to the abbreviated 510k pathway.