Rule Rule 333-106-0355
CT Equipment Requirements


CT equipment requirements shall comply with the Food and Drug Administrations 21 CFR in the following areas:


Information to be provided for users Part 1020.33(c);


Quality Assurance Part 1020.33(d);


Control and indication of conditions of operation Part 1020.33(f);


Tomographic plane indication and alignment Part 1020.33(g);


Beam-on and status indicators Part 1020.33(h);


Scan increment accuracy Part 1020.33(i); and


CT number mean and standard deviation Part 1020.33(j).


CT equipment shall be maintained in compliance with the requirements of section (1) of this rule.
Last accessed
Mar. 28, 2020