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FDAnews Device Daily Bulletin
Oct. 31, 2012 | Vol. 9 No. 214
Radiology Panel Gives Thumbs Up to New 3-D Mammography Use
The FDA’s Radiological Devices Advisory Panel voted Wednesday to support expanded indications for the Hologic Selenia Dimensions C-View Software Module when used with the Selenia 3-D mammography device. Selenia has the ability to perform both 3-D imaging and standard full-field digital mammography (FFDM) imaging, but the C-View’s current indication only allows for its use in conjunction with FFDM reading.
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