X-ray tube

X-ray tube means any electron tube which is designed for the conversion of electrical energy into x-ray energy.







(iv)(A) Components installed temporarily in an x-ray system in place of components removed temporarily for repair, provided the temporarily installed component is identified by a tag or label bearing the following information:































(i) For each mode of operation, a description of the mode and detailed instructions on how the mode is engaged and disengaged. The description of the mode shall identify those technique factors and system controls that are fixed or automatically adjusted by selection of the mode of operation, including the manner in which the automatic adjustment is controlled. This information shall include how the operator can recognize which mode of operation has been selected prior to initiation of x-ray production.








Warning label. The control panel containing the main power switch shall bear the warning statement, legible and accessible to view:
“Warning: This x-ray unit may be dangerous to patient and operator unless safe exposure factors, operating instructions and maintenance schedules are observed.”

Source

21 CFR § 1020.30


Scoping language

None
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