4Dx Limited -First of it's Kind Lung Imaging Technology, page-7

4Dx Completes FDA Submission Documentation; As of November 10, 2019, 4Dx is proud to announce that all documents required to support an FDA 510(k) application have been handed over to its agent for electronic submission. After a tremendously successful clinical validation trial, 4Dx founder and CEO, Andreas Fouras, was very happy to announce the trial’s results, which showed that 4Dx’s core platform, XV Technology™ was superior to current modalities in detecting and locating the loss of lung function, either due to disease or side-effects of treatments. The first commercial product within the XV Technology family being examined by the FDA is the 4Dx Ventilation Report. It is 4Dx’s first commercial offering to enter into global healthcare markets, with the intent to begin with market-entry in the U.S., China and Australia
http://4dx.com/4dx-completes-fda-submission-documentation/
http://www.fda.gov/