21 CFR § 892.5650 - Manual radionuclide applicator system.

---
identifier: "/us/cfr/t21/s892.5650"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.5650 - Manual radionuclide applicator system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.5650"
section_name: "Manual radionuclide applicator system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 892.5650 Manual radionuclide applicator system.

(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.

[53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000]