| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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| Trade Name | KODAK MAMMOGRAPHY CAD ENGINE |
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| Classification Name | analyzer,medical image |
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| Generic Name | analyzer, medical image |
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| Applicant | CARESTREAM HEALTH,INC. |
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| PMA Number | P030007 |
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| Date Received | 03/31/2003 |
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| Decision Date | 11/23/2004 |
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Withdrawal Date
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11/13/2012 |
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| Product Code | |
| Docket Number | 05M-0087 |
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| Notice Date | 03/09/2005 |
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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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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the kodak mammography cad engine. The kodak mammography cad engine is a software package intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the software assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review. |
| Approval Order |
Approval Order
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| Supplements: |
S001 S003 |
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