You seem to have some difficulty with opinion and fact, gdsgds. Saying something multiple times doesn't make it true and saying what you want the truth to be doesn't make it true.
The FDA is not stupid.
This is an opinion. The FDA is every bit as smart/stupid as your average government agency. I don't think the IRS or DMV would win any awards for competence, but that's just me. In fact, if you looked at how many device manufacturer's complained about the 510k process, you could make a convincing argument the FDA is doing something wrong.
They have a huge legal deaprtment.
This is a fact. They are frequently sued by people over things they did approve and things they didn't approve. I fail to see how that affects anything here.
They refused to show me the working machine.
This is a fact. Would you expect to visit Ford's design campus and ask to see their Mustang prototype? No, you'd ask, they'd show you a mock-up and some drawings, if that.
All I saw was a 2d machine
This is an opinion. Who here among us is qualified to look at the DVIS mock-up, know its internal componnents, software design, and conclusively say "this is a 2d only machine". If someone is, schedule a trip to Burbank and see if they'll let you in.
With zip ties and transformers.
This is a fact, but not a bad one. As a prototype (and the first prototype according to Dean), the machine is designed for gantry tests and data gathering. If you've ever seen a prototype stage electronic device of any kind, you'd see all kind's of shortcuts, quick disconnects, experimental connections, etc. that are not used in production. According to Dean, the next version of the prototype is at a secure off-site facility.
From the 70's.
Transformers have not changed much since they were invented. Take apart a modern PC power supply and a guitar amplifier from 1965 and you'll see a transformer that looks pretty much the same.
It is beyond me how you can make this machine portable or move it from one room to another. It's huge, heavy, and won't go thru any door unless it's an industrial door.
This is an opinion. First, you saw the first prototype. Prototypes of electronic devices are frequently made more open/larger/easier access because they need to be for tests and modifications. Unless you tried to move it, you have no idea how heavy it is or how mobile.
The FDA was clear, the rejection is due to lack of compatability between the material presented and the field unit.
The is an opinion. Quite frankly, unless you have the NSE letter in front of you, we have no idea what the FDA's specific beef was with the DVIS.
