§ 892.1715. Full-field digital mammography system.
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/us/cfr/t21/s§ 892.1715·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 892.1715
Full-field digital mammography system.
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