21 C.F.R. § 892.5840

Radiation therapy simulation system.

Last amended: 2016Year: 2026Length: 67 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 892.5840 (2026)

(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.
21 C.F.R. § 892.5840: Radiation therapy simulation system. | Justis AI