21 CFR 872.1800 — Unit, X-Ray, Extraoral With Timer

Dental (DE) · Subpart B—Diagnostic Devices · § 872.1800

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.

Classification Rationale

Class II.

Product Codes

Product CodeDevice NameClassDevicesAttributes
EHDUnit, X-Ray, Extraoral With Timer21893rd Party
MUHSystem, X-Ray, Extraoral Source, Digital22063rd Party
Innolitics

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