CFR section

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

PART 1020-PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

Key facts

Citation 21 CFR 1020.33(c)(2)(i)(c)
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) (c) Along lines parallel to the axis of rotation and 1.0 centimeter interior to the surface of the phantom at positions 90, 180, and 270 degrees from the position in paragraph (c)(2)(i)(b) of this section. The CT conditions of operation shall be the typical values suggested by the manufacturer for CT of the head or body. The location of the position where the CTDI is maximum as specified in paragraph (c)(2)(i)(b) of this section shall be given by the manufacturer with respect to the housing of…

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