---
kind: "section"
citation: "21 C.F.R. § 892.1715"
title: "21"
number: "892.1715"
heading: "Full-field digital mammography system."
url: "https://uscodex.org/cfr/21/892.1715"
---

# §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)](/cfr/21/892.1.md?p=e) for the availability of this guidance document.

## Notes

### Amendments

[75 FR 68203, Nov. 5, 2010]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 1567, Jan. 20, 1988, unless otherwise noted.

### Amendments

[75 FR 68203, Nov. 5, 2010]