Do you remember what it's already happened for? Do you know what devices they're equivalent to?
While I get the impression FDA and industry prefer 510ks as much as possible, personally I don't see how this is close enough to anything out there right now for that to pass the smell test.
My guess would be that some `Watson` equivalent stuff will be 510k'd in as part of an MRI, CT or DBT imaging system or a CAD tool working on these systems. I think it'd take a while though, I don't think the regulatory science is there yet for actually showing value.
While I get the impression FDA and industry prefer 510ks as much as possible, personally I don't see how this is close enough to anything out there right now for that to pass the smell test.
My guess would be that some `Watson` equivalent stuff will be 510k'd in as part of an MRI, CT or DBT imaging system or a CAD tool working on these systems. I think it'd take a while though, I don't think the regulatory science is there yet for actually showing value.