GroundRules
21 CFR 892.1760: Diagnostic x-ray tube housing assembly.
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 tube housing assembly is an x-ray generating tube encased in a radiation-shielded housing that is intended for diagnostic purposes. This generic type of device may include high voltage and filament transformers or other appropriate components.
(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