GroundRules
21 CFR 892.1700: Diagnostic x-ray high voltage generator.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 892—RADIOLOGY DEVICES
- Subpart B—Diagnostic Devices
(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.
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON