21 CFR § 892.1715 - Full-field digital mammography system.
---
identifier: "/us/cfr/t21/s892.1715"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 892.1715 - Full-field digital mammography system."
title_number: 21
title_name: "Food and Drugs"
section_number: "892.1715"
section_name: "Full-field digital mammography 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"
---
# 892.1715 Full-field digital mammography system.
(a) *Identification.* A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.
(b) *Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.” *See* § 892.1(e) for the availability of this guidance document.
[75 FR 68203, Nov. 5, 2010]