eCFR Reference Browser

---

title: "21 CFR §892.5650"

source: "https://www.ecfr.gov/current/title-21/section-892.5650"

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: "892.5650"

section_subject: "Manual radionuclide applicator system."

cfr_reference: "21 CFR 892.5650"

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 manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

(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 § 892.9.

§892.5650 - Manual radionuclide applicator system.