21 CFR § 892.1950 - Radiographic anthropomorphic phantom.

---
identifier: "/us/cfr/t21/s892.1950"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1950 - Radiographic anthropomorphic phantom."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1950"
section_name: "Radiographic anthropomorphic phantom."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "892"
part_name: "RADIOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "53 FR 1567, Jan. 20, 1988, unless otherwise noted."
cfr_part: "892"
---


# 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 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]