The Food and Drug Administration (FDA) path is estimated to cost several million dollars. The lions share of the money would be spent to buy consultants and lawyers but some will also be used to develop a production model and documentation according to esoteric specifications. A feeding trough of companies staffed by ex-FDA employees is ready and available to help. The end result of all this spending is a package that can be presented to the FDA in a form that the department wants.
The FDA path would be a private effort because the public company Imaging3 tried and failed and is now dead. The technology has been transferred out of the company. What remains of Imaging3, the IGNG stock symbol, has been sold to dope peddlers.
The benefit of this path is that the investor would have access to the largest single unified market in the world: the United States, and Europe quickly and easily follows suit. The risk of this path is that it costs much more than the non-FDA track and FDA approval is not certain.
The non-FDA path is estimated to cost as well. However, the lions share of the money would be spent on product development. It would be a partnership between a machine shop or manufacturer and the Polish software developer.
The risk of this path is that the investor would be able to sell to non-USA/EU markets only. The benefit of this path is that there is a huge market and need for the product in these areas.
The non-FDA path allows for change some time down the line. Once the heavy lifting to get FDA approval for the product is completed by someone else, then it is much easier to get approval for a similar product to one that has already been through the system.
The truth is that FDA approval will most probably never take place. The original Imaging3 strategy was to get FDA approval then be bought out along with patent by a big medical imaging firm. The problem with this approach is that Imaging3 is an external disruptor. Agitators do not influence the industry they are to replace from within. The status quo is just fine with $2 million dollar machines that fry people with radiation. They do not want or need machines on the market in the hundred thousand dollar range.
There is also the issue of patents. The patent is for a continuous aka "real-time" scan device used for medicine in the United States not single safe scan. The patent was for Dean Janes' dream machine. The safe scan was a variation which was only possible to pursue after Dean Janes left the firm. Jack Tuszynski along with Dane Medley came up with the idea. The concept was based on extremely short scans performed by the NASA/TES spacecraft instrument during earth flyovers.