Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025
§ 892.1630 - Electrostatic x-ray imaging system.

(a) Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

authority: 21 U.S.C. 351,360,360c,360e,360j,360
source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.
cite as: 21 CFR 892.1630