A reason

There are many reasons why I suspect that Nanox did not submit anything to anyone for FDA clearance, or if it did, it did so fraudulently. 

Here is one.

It is February 7, 2020. The month of January had been very exciting at Nanox because the team finally submitted the super-secret single-source device for FDA clearance, after getting it to work and completing extensive testing with it at Hadassah.  No more need for fake videos showing fake tests of fake devices.  Right? Everybody is excited and still celebrating - even the lawyers and the assistants know what Nanox has achieved - they are getting rich! So what does Nanox do? It files a draft registration statement with the SEC and states on page 1: 

As a first step, we plan to submit a 510(k) application for a single-source version of the Nanox.Arc to the U.S. Food and Drug Administration (the “FDA”) in January 2020.

Plan to submit?  But it is February 7 already!  It should read "we submitted!"   How come whoever wrote the filing forgot about the submission?  On page 1, not buried on page 146 or something...

And what else do we learn in that draft registration statement on page 9?

We have not produced a working prototype of the Nanox.Arc

Wait, what?  How can you do testing, if you don't even have a working prototype?   Where did all the numbers and images in the submission come from?  How did Nanox write these sections in the submission without a working device:  Specifications , Substantial Equivalence Comparison, and Performance? 

Note that regulations require that all

510(k) submitters must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. 

So, did Nanox file a false draft registration statement with the SEC, or did Nanox made false statements to the FDA, or maybe both?

Note:  The fake video of the fake device titled "Nanox ARC  -  Raw chest scan demonstration," that was later "updated," was initially encoded on February 25, 2020.  Here is a snapshot.

Update April 5, 2021:  Nanox got clearance for a Nanox.Cart (the ugly device, not the one shown here).  So, the draft registration filing was erroneous or the clearance submission was fraudulent.  More hints will be revealed in the summary that will be published around May 1st.