Title 21: Food and Drugs
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/ PART 892 - RADIOLOGY DEVICES
/ Subpart B - Diagnostic Devices / § 892.1610 Diagnostic x-ray beam-limiting device.
§ 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.