21 C.F.R. § 892.1950 Radiographic anthropomorphic phantom.
Title 21 - Food and Drugs
(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 regulations 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]
Title 21: Food and Drugs
PART 892—RADIOLOGY DEVICES
Subpart B—Diagnostic Devices
§ 892.1950 Radiographic anthropomorphic phantom.
