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Diagnostic Imaging as related to Drug and Medical Device Safety


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CAT Scan; Computed Tomography; CT; Nuclear Medicine Tests; Radionuclide Scans 

Medical Devices 

Medical imaging is the process by which physicians evaluate an area of the subject's body that is not normally visible. Medical imaging may be "clinical", seeking to diagnose and examine disease in specific human patients (see pathology). Alternatively, it may be research-motivated, attempting to understand processes in humans or animal models. Many of the techniques developed for medical imaging also have scientific and industrial applications.

A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:* recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, * intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or * intended to affect the ...


Diagnostic Imaging as related to Drug and Medical Device Safety


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July 26, 2008



Page Updated: June 12, 2007
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