21 CFR § 892.1310 - Nuclear tomography system.

---
identifier: "/us/cfr/t21/s892.1310"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1310 - Nuclear tomography system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1310"
section_name: "Nuclear tomography 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"
---


# 892.1310 Nuclear tomography system.

(a) *Identification.* A nuclear tomography system is a device intended to detect nuclear radiation in the body and produce images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of devices may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

(b) *Classification.* Class II.