SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P080003 · decided 2011-02-11
Approval details
- PMA number
- P080003
- Trade name
- SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2008-01-22
- Decision date
- 2011-02-11
- Days to decision
- 1116 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 2D MAMMOGRAPHY SYSTEMS FOR SCREENING MAMMOGRAMS. SPECIFICALLY, THE SELENIA DIMENSIONS SYSTEM CAN BE USED TO ACQUIRE 2D DIGITAL MAMMOGRAMS AND 3D MAMMOGRAMS. THE SCREENING EXAMINATION WILL CONSIST OF A 2D IMAGE SET OR A 2D AND 3
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