Regulation Text
(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 .
Authority
21 U.S.C. 351,360,360c,360e,360j,360l,371.