21 CFR § 892.1710 - Mammographic x-ray system.

---
identifier: "/us/cfr/t21/s892.1710"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1710 - Mammographic x-ray system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1710"
section_name: "Mammographic 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"
---


# 892.1710 Mammographic x-ray system.

(a) *Identification.* A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) *Classification.* Class II.