21 CFR 892.1200 — System, Tomography, Computed, Emission

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1200

Identification

An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.

Classification Rationale

Class II.

Product Codes