There are other ways to prove this thing works without the FDA caring. A letter from a radiogists stating this is working or somekind of medical write up.
The reason I and others are asking is Dean's reputation at this time has suffered a commplete meltdown on the honesty side. Hopefully MWE is on board. The new 510 K shouldn't be taking this long? It sounds like the company new this was coming well before the official NSE letter.