Digital Breast Tomosynthesis
Basic Information
- Device Name
- Digital Breast Tomosynthesis
- Trade Name
- SENOCLAIRE
- PMA Number
- P130020
- Device Class
- FDA Class 3
- Product Code
- OTE
- Generic Name
- Digital breast tomosynthesis
- Medical Specialty
- Unknown
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 26, 2014
- Date Received
- July 17, 2013
- Expedited Review
- N
- Docket Number
- 14M-1279
Advisory Committee Statement
APPROVAL FOR THE SENOCLAIRE. THIS DEVICE IS INDICATED FOR THE ACQUISITION OF 2D IMAGES AND ALSO FOR THE ACQUISITION OF MULTIPLE PROJECTION VIEWS INTENDED TO PRODUCE 3D DBT IMAGES SUITABLE FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. SENOCLAIRE CAN BE USED FOR THE SAME CLINICAL APPLICATIONS AS TRADITIONAL MAMMOGRAPHY FOR SCREENING MAMMOGRAPHY. A SCREENING EXAMINATION WILL CONSIST OF:1) 2D IMAGE SET CONSISTING OF A CRANIOCAUDAL VIEW AND OF A MEDIOLATERAL OBLIQUE VIEW, OR 2) A 2D CRANIOCAUDAL VIEW AND 3D MEDIOLATERAL OBLIQUE IMAGE SET.THE SENOCLAIRE DIGITAL BREAST TOMOSYNTHESIS (DBT) OPTION TO SENOGRAPHE ESSENTIAL FFDM SYSTEM MAY ALSO BE USED FOR ADDITIONAL DIAGNOSTIC WORKUP OF THE BREAST.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OTE | Digital Breast Tomosynthesis | FDA class 3 | Unknown |