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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceHOLOGIC SELENIA DIMENSIONS 2D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
HOLOGIC, INC.
36 apple ridge road
danbury, CT 06810
PMA NumberP010025
Supplement NumberS019
Date Received06/01/2010
Decision Date11/16/2010
Product Code
MUE
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for additional automatic exposure control (aec) technique tables. The device, as modified, will be marketed under the trade name selenia dimensions 2d full field digital mammography system.
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