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Title 21 Part 892 → Subpart F → §892.5840

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart F → §892.5840

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart F → §892.5840

e-CFR data is current as of September 12, 2019

Title 21Chapter ISubchapter HPart 892Subpart F → §892.5840


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart F—Therapeutic Devices


§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.