Code of Federal Regulations · Section

§ 892.1770 — Diagnostic X-ray Tube Mount

21 C.F.R. § 892.1770

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(a) Identification. A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.

(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.

Authorizing Statute