21 CFR § 892.1750 - Computed tomography x-ray system.

---
identifier: "/us/cfr/t21/s892.1750"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1750 - Computed tomography x-ray system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1750"
section_name: "Computed tomography x-ray 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"
---


# 892.1750 Computed tomography x-ray system.

(a) *Identification.* A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) *Classification.* Class II.