Rule Rule 333-106-0010
Administrative Controls


Registrants shall be responsible for directing the operation of the X-ray system(s) under their administrative control. The registrant or the registrant’s agent shall assure that the requirements of this rule are met in the operation of the X-ray system(s).


An X-ray system and/or the operation of the X-ray system which does not meet the provisions of these rules shall not be operated for diagnostic or therapeutic purposes.


For X-ray equipment manufactured after July 31, 1974, the registrant shall assure that the equipment will remain in compliance with the Code of Federal Regulations, Title 21.
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Feb. 4, 2021