21 C.F.R. § 872.1800 Extraoral source x-ray system.
Title 21 - Food and Drugs
(a) Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts. (b) Classification. Class II.
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart B—Diagnostic Devices
§ 872.1800 Extraoral source x-ray system.
