| 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 | KODAK MAMMOGRAPHY CAD ENGINE |
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| Generic Name | Analyzer, medical image |
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| Regulation Number | 892.2070 |
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| Applicant | CARESTREAM HEALTH,INC.
150 Verona Street
ROCHESTER, NY 14608 |
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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 |
MYN |
| 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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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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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S003 |
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|
