21 CFR 892.1715 — Full Field Digital, System, X-Ray, Mammographic
Radiology (RA) · Subpart B—Diagnostic Devices · § 892.1715
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | 2 | 59 | 3rd Party |
Special Controls
MUE — Full Field Digital, System, X-Ray, Mammographic
*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.
eCFR
