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Title 21 Part 892 → Subpart B → §892.1700

Title 21 → Chapter I → Subchapter H → Part 892 → Subpart B → §892.1700

Electronic Code of Federal Regulations e-CFR

Title 21 Part 892 → Subpart B → §892.1700

e-CFR data is current as of September 18, 2019

Title 21Chapter ISubchapter HPart 892Subpart B → §892.1700


Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices


§892.1700   Diagnostic x-ray high voltage generator.

(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.

[53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, 2001]