21 CFR § 892.5700 - Remote controlled radionuclide applicator system.

---
identifier: "/us/cfr/t21/s892.5700"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.5700 - Remote controlled radionuclide applicator system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.5700"
section_name: "Remote controlled 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"
---


# 892.5700 Remote controlled radionuclide applicator system.

(a) *Identification.* A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, 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 II.