21 CFR § 892.1770 - Diagnostic x-ray tube mount.
§ 892.1770 Diagnostic x-ray tube mount.
(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.