StacksVerified U.S. regulatory reference

21 CFR §892.1740

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (a)Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
  2. (b)Classification. Class II.