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RE: "X-Ray Machine" and "Accelerator" Definitions
Let me suggest that, whether or not it is possible to differentiate between
accelerators and x-ray machines based on principle, that is more or less
irrelevant from a regulatory point of view. FDA defines diagnostic x-ray
machine based on its intended use (21 CFR 1020.30(b)), and doesn't really
care that much how it generates the x-rays, although the conventional method
of acceleration of electrons is expected in most cases. If it is an 'x-ray
system intended for irradiation of any part of the human body for the
purpose of diagnosis or visualization', then it fits the definition and is
probably covered.
This is probably necessary from the regulators point of view. I would
expect most state definitions to follow this model.
I take your point that, from a physics point of view, there may not be any
difference.
Charles K. Showalter
Director, Federal Programs
American College of Radiology
PH: 703-648-8982
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