CFR section

21 CFR 1020.33(c)(2)(ii): Computed tomography (CT) equipment

PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

Key facts

Citation 21 CFR 1020.33(c)(2)(ii)
Section Computed tomography (CT) equipment
Part PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
Subchapter 21 CFR J Radiological
Product types cited Devices
Regulation text (excerpt) (ii) The CTDI in the center location of the dosimetry phantom for each selectable CT condition of operation that varies either the rate or duration of x-ray exposure. This CTDI shall be presented as a value that is normalized to the CTDI in the center location of the dosimetry phantom from paragraph (c)(2)(i) of this section, with the CTDI of paragraph (c)(2)(i) of this section having a value of one. As each individual CT condition of operation is changed, all other independent CT conditions of…

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