i think so --- it appears so... which is what i had inferred from the initial reasons on request for the QA high contrast low contrast imagery by the FDA... knowing what high contrast and low contrast means, i thought well the FDA is getting it, the concept of the device... by at least wanting to look at what we inspect annually or biannually for CT (as well as fluoroscopy). however, i don't want to take a guess as to what the predicate substantially equivalent device(s) is/are going to be as appears on the application... although, in the clearance letter by the FDA, it will state it, and thus we will find out.
pertaining to the concept of the device as a combo device, i really don't even know if the FDA allows an applicant to list more than one predicate device. i can't remember for sure ever noting that on the one's i've looked at. i know patents do allow this, as it is critical to the application process for patents... regardless if the FDA wanted to look at high low contrast imagery for the CT feature of the DViS then i still think they get the point...that this is a mobile fluoroscope/cone beam CT device.
bottom line: i can't imaging the labeling aspect cutting off one or the other... as there is such a thing as CT-fluoroscopy, simply put, that is just running a CT scanner continuously and updating the slices continuously through the imaging chain as viewed, it isn't nearly the same thing as a fluoroscope and doesn't even come close to what the DViS does in fluoroscopy mode...
