Replies to post #16332 on Grapefruit USA Inc (GPFT)

[Arlo1945]

"The one big thing that they are asking for is a third party Radiologist read of our images and compared to an existing device on the market. The device we are comparing to is basically a c-arm, which is 2D Fluoroscopy. The DViS can do this type of imaging right now and in seconds, we do not see any issues or problems with complying with this request, it's pretty simple actually."

I really think you're interpreting this the wrong way. It says, "the device we are COMPARING TO is...." as in they're referring to a device comparable to DViS' 2D images. But this excerpt alone really doesn't tell the whole story and what the whole context of the email is really saying. There is still a lot of ambiguity in it.

[IMGGorBust]

There is no single device on the market that does all of the things that the DViS does. Specifically, no other single device can deliver: (1) 3D Imaging (fluoro and CT); (2) 16 slice CT; and (3) 2D fluoro. Accordingly, for purposes of substantial equivalence, Imaging3 is comparing the DViS to 3 different devices. One of them is a 2D fluroscopy device, one is a CT device that generates 16-slice CT images. The last is a device that creates 3D images (although not in real time). Accordingly, with the Radiologists Review in the April 5 package, Imaging3 proivded (1) 2D fluoro images from both the DViS and the 2D fluoro predicate device; (2) DViS images in the 16 slice CT modality from the DViS and the CT predicate device; and (3) DViS images in the 3D fluoro modality and comparable images from the 3D predicate device. All three sets of images from the DViS and all 3 sets of images from the 3 different predicated devices were sent.

Fact.