§ 892.1920. Radiographic head holder.
109 words·~1 min read·
/us/cfr/t21/s§ 892.1920·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A radiographic head holder is a device intended to position the patient's head during a 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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025]