Grapefruit USA Inc (GPFT)

[Woodberry578]

Wow! Thanks. I have been around for 5 years, so yes I remember the IDE ruling by the FDA. You seem to forget that the company decided to go the 510K route instead of the IDE route, so they could not test the device ANYWHERE per the FDA! Go back and show me where the company said they were testing the device someplace.

Sites did want to test the machine, and they had sites picked out, but when the decision was made to do a 510K instead, Imaging3 had to change direction from placing machines as that would be a violation of FDA policy.