21 CFR § 892.1730 - Photofluorographic x-ray system.
---
identifier: "/us/cfr/t21/s892.1730"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1730 - Photofluorographic x-ray system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1730"
section_name: "Photofluorographic x-ray system."
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"
---
# 892.1730 Photofluorographic x-ray system.
(a) *Identification.* A photofluorographic x-ray system is a device that includes a fluoroscopic x-ray unit and a camera intended to be used to produce, then photograph, a fluoroscopic image of the body. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
(b) *Classification.* Class II (special controls). A discography kit intended for use with a photofluorographic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71819, Dec. 30, 2019]