21 CFR 892.1760 — Assembly, Tube Housing, X-Ray, Diagnostic

Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1760

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.

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

Product CodeDevice NameClassDevicesAttributes
ITYAssembly, Tube Housing, X-Ray, Diagnostic140
Innolitics

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