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Device | SELENIA DIMENSIONS 3D SYSTEM |
Generic Name | Digital breast tomosynthesis |
Applicant | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 |
PMA Number | P080003 |
Supplement Number | S001 |
Date Received | 10/09/2012 |
Decision Date | 05/16/2013 |
Product Code |
OTE |
Docket Number | 13M-0595 |
Notice Date | 05/23/2013 |
Advisory Committee |
Radiology |
Clinical Trials | NCT00971087
|
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE SELENIA DIMENSIONS 3D SYSTEM. THIS DEVICE IS INDICATED TO GENERATE DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SELENIA DIMENSIONS (2D OR 3D) SYSTEM IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS A 2D MAMMOGRAPHY SYSTEM FOR SCREENING MAMMOGRAMS. SPECIFICALLY, THE SELENIA DIMENSIONS SYSTEM CAN BE USED TO GENERATE 2D DIGITAL MAMMOGRAMS AND 3D MAMMOGRAMS. EACH SCREENING EXAMINATION MAY CONSIST OF: A 2D FFDM IMAGE SET; OR A 2D AND 3D IMAGE SET, WHERE THE 2D IMAGE CAN BE EITHER A FFDM OR A 2D IMAGE GENERATED FROM THE 3D IMAGE SET. THE SELENIA DIMENSIONS SYSTEM MAY ALSO BE USED FOR ADDITIONAL DIAGNOSTIC WORKUP OF THE BREAST. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |