Title 21

SECTION 892.1950

892.1950 Radiographic anthropomorphic phantom.

§ 892.1950 Radiographic anthropomorphic phantom.

(a) Identification. A radiographic anthropomorphic phantom is a device intended for medical purposes to simulate a human body for positioning radiographic equipment.

(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 system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001]