21 CFR 892.1700 — Generator, High-Voltage, X-Ray, Diagnostic

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1700

Identification

A diagnostic x-ray high voltage generator is a device that is intended to supply and control the electrical energy applied to a diagnostic x-ray tube for medical purposes. This generic type of device may include a converter that changes alternating current to direct current, filament transformers for the x-ray tube, high voltage switches, electrical protective devices, or other appropriate elements.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.

Product Codes