§ 892.1610 — Diagnostic X-ray Beam-limiting Device

(a) Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.

(b) Classification. Class II (special 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.