SELENIA DIMENSIONS 3D SYSTEM
FDA premarket approval P080003/S001 · decided 2013-05-16
Approval details
- PMA number
- P080003
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELENIA DIMENSIONS 3D SYSTEM
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2012-10-09
- Decision date
- 2013-05-16
- Days to decision
- 219 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- 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
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