eCFR Reference Browser

---

title: "21 CFR §892.5840"

source: "https://www.ecfr.gov/current/title-21/section-892.5840"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "892"

part_subject: "RADIOLOGY DEVICES"

subpart_code: "F"

subpart_subject: "Therapeutic Devices"

section_number: "892.5840"

section_subject: "Radiation therapy simulation system."

cfr_reference: "21 CFR 892.5840"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

§892.5840 - Radiation therapy simulation system.