21 CFR 892.5840 - Radiation therapy simulation system.
(a)Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.
(b)Classification. Class II.
Title 21 published on 2015-12-03.
No entries appear in the Federal Register after this date, for 21 CFR Part 892.