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Title 21 Part 892 → Subpart F → §892.5740

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart F → §892.5740

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart F → §892.5740

e-CFR data is current as of October 16, 2019

Title 21Chapter ISubchapter HPart 892Subpart F → §892.5740


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


§892.5740   Radionuclide teletherapy source.

(a) Identification. A radionuclide teletherapy source is a device consisting of a radionuclide enclosed in a sealed container. The device is intended for radiation therapy, with the radiation source located at a distance from the patient's body.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §892.9.

[53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, 2001]


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