In short, we are not a medical device, we simply display data from the medical devices. This means that the FDA does not apply its regulatory oversight to our product.
​
We base this assertion on the following guidance issued by the the FDA:
​
​https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices
​
The functionality discussed clearly covers the type of software Xchart provides.

​