[ltowel]

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.

[ska]

Off the top of my head, I don't, but I'll have a look if I have a chance later.

There have been approved CAD systems separate from imaging systems since the 90s.

"Value" is a nebulous term. FDA looks specifically for "safety & efficacy", and the criterion for each are rather dependent on the intended use.