| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | SENOCLAIRE |
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| Generic Name | Digital breast tomosynthesis |
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| Applicant | GE Healthcare
3000 N. GRANDVIEW BLVD
WAUKESHA, WI 53188 |
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| PMA Number | P130020 |
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| Date Received | 07/17/2013 |
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| Decision Date | 08/26/2014 |
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| Product Code |
OTE |
| Docket Number | 14M-1279 |
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| Notice Date | 09/02/2014 |
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| Advisory Committee |
Radiology |
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| Clinical Trials | NCT00535184
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 |
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