21 CFR §892.1700

1. (a)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.
2. (b)Classification. 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.