StacksVerified U.S. regulatory reference

21 CFR §892.1710

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
  1. (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.
  2. (b)Classification. Class II.