21 CFR § 892.1310 Radiology Devices

§ 892.1310 Nuclear tomography system.

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

⚠ 3 pending changes to Part 892

(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.

← § 892.1300 Nuclear rectilinear scanner.§ 892.1320 Nuclear uptake probe. →