ARSD 44:03:01:08.08. Equipment standards for computed tomography systems

A computed tomography (CT) system must meet the specifications in 21 C.F.R. §§ 1020.30 and 1020.33, in effect on April 1, 2022. In addition, a CT system must meet the following standards: (1) The system must provide for two-way, oral communication between the patient and the operator at the control panel; (2) Leaded windows, mirrors, a closed-circuit television, or an equivalent must be located to permit the operator to continuously observe the patient during irradiation from the control panel; and (3) If the primary viewing system is by electronic means, an alternate viewing system, which may be electronic, must be available for use if the primary viewing system fails.