Grapefruit USA Inc (GPFT)

[goldcoastoh]

yes images were QA (quality assurance), and remember they were pertinent to the CT (i.e., cone beam CT) feature only...as we understood from previous...

in the world of CT, the QA aspect is what an operator would do for documenting the units are calibrated to standards for quality control.

however, annually or biannually a medical physicist ensures high/low contrast (among other batteries of tests, referred to as physics acceptance standards), and annually companies do PM, i.e., preventative maintenance.

i take the actual requested images (now old news, as they were submitted and now the FDA just wants to finalize labeling) this to mean that the FDA took the CT component seriously.

by the way, both acceptance testing and PMs are done in fluoro too. so the same concepts would apply to the fluoro features. QA as far as imagery isn't really necessary for daily/weekly performance in mobile fluoro...

the concepts of these tests are to provide objective data (both for the FDA and for the real world ultimately upon clearance), and is why patient or clinical images aren't necessary.

thanks for writing up the synopsis...