Final guidance document on manufacturers' information disclosure for diagnostic x-ray systems

Mar 26, 2001

Manufacturers are required to disclose information on assembly, installation, adjustment and testing (AIAT) to ensure that x-ray systems will meet U.S. performance standards. The information helps ensure compliance with performance standards that keep x-ray exposure levels as low as possible.

http://www.fda.gov/cdrh/comp/guidance/2619.html

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