| 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 | SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
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| Generic Name | Full field digital, system, x-ray, mammographic |
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| Regulation Number | 892.1715 |
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| Applicant | HOLOGIC, INC.
35 CROSBY DR.
BEDFORD, MA 01730 |
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| PMA Number | P010017 |
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| Date Received | 03/13/2001 |
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| Decision Date | 09/25/2001 |
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Reclassified Date
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12/06/2010 |
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| Product Code |
MUE |
| Docket Number | 01M-0509 |
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| Advisory Committee |
Radiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
APPROVAL FOR THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE DEVICE IS A DEDICATED MAMMOGRAPHY SYSTEM INTENDED TO PRODUCE RADIOGRAPHIC IMAGES OF THE HUMAN BREAST FOR THE PURPOSE OF DIAGNOSTIC AND SCREENING MAMMOGRAPHY. THE SENOSCAN(R) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHY SYSTEMS. |
| 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: |
S007 S004 S005 |
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