21 CFR § 892.1630 - Electrostatic x-ray imaging system.

---
identifier: "/us/cfr/t21/s892.1630"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1630 - Electrostatic x-ray imaging system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1630"
section_name: "Electrostatic x-ray imaging 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"
---


# 892.1630 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.