| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
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| Classification Name | full field digital,system,x-ray,mammographic |
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| Regulation Number | 892.1715 |
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| Applicant | HOLOGIC, INC. |
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| PMA Number | P010025 |
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| Supplement Number | S001 |
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| Date Received | 03/29/2002 |
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| Decision Date | 10/02/2002 |
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| Product Code | |
| Advisory Committee |
Radiology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - component |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for an amorphous selenium digital receptor, a change in the name of the product to selenia and the addition of a soft copy display for interpretation of screening and diagnostic mammograms. The device, as modified, will be marketed under the trade name selenia full field digital mammography system and is indicated for generating digital mammographic images that can be used for screening and diagnosis of breast cancer. The selenia full field digital mammography system is intended for use in the same clinical applications as traditional screen-film mammographic systems. Mammographic images can be interpreted on either hard copy film or the selenia soft copy review workstation. Also, approval for the addition of the lorad facility, danbury, connecticut, as a manufacturing site for the selenia full field digital mammography system. |
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