21 CFR § 892.1750 Radiology Devices

§ 892.1750 Computed tomography x-ray system.

Current through Sep 8, 2026 · Read all of Part 892

⚠ 3 pending changes to Part 892

(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.

← § 892.1740 Tomographic x-ray system.§ 892.1760 Diagnostic x-ray tube housing assembly. →