Title 21 Part 892 → Subpart B → §892.1310

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1310

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1310

e-CFR data is current as of February 13, 2020

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1310

Title 21: Food and Drugs
Subpart B—Diagnostic Devices

§892.1310   Nuclear tomography system.

(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.