Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
Part 892 - Radiology Devices |
Subpart B - Diagnostic Devices |
§ 892.1710 - Mammographic x-ray system.
Latest version.
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§ 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.