§892.1920. Radiographic head holder.
21 C.F.R. § 892.1920
Identification. A radiographic head holder is a device intended to position the patient's head during a radiographic procedure.
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.
Notes, amendments, and revision history
Amendments
[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
Amendments
[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001; 90 FR 55995, Dec. 4, 2025]