21 CFR 892.5710 - Radiation therapy beam-shaping block.

§ 892.5710 Radiation therapy beam-shaping block.

(a)Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

(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.

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United States Code

Title 21 published on 10-May-2017 03:43

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

  • 2014-01-17; vol. 79 # 12 - Friday, January 17, 2014
    1. 79 FR 3088 - Effective Date of Requirement for Premarket Approval for Transilluminator for Breast Evaluation and Sorbent Hemoperfusion System (SHS) Devices for the Treatment of Hepatic Coma and Metabolic Disturbances; Reclassification of SHS Devices for the Treatment of Poisoning and Drug Overdose
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective January 17, 2014.
      21 CFR Parts 876 and 892