21 CFR 892.5900 - X-ray radiation therapy system.

§ 892.5900 X-ray radiation therapy system.

(a)Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. 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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 892 after this date.

  • 2018-01-05; vol. 83 # 4 - Friday, January 5, 2018
    1. 83 FR 600 - Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective January 5, 2018. The classification was applicable on April 1, 2015.
      21 CFR Part 892