| 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 DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY |
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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 | CARESTREAM HEALTH, INC.
150 Verona Street
ROCHESTER, NY 14608 |
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| PMA Number | P080018 |
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| Date Received | 07/28/2008 |
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| Decision Date | 11/03/2010 |
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Reclassified Date
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12/06/2010 |
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| Product Code |
MUE |
| Docket Number | 10M-0591 |
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| Notice Date | 11/23/2010 |
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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 KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM. THE DEVICE IS INDICATED FOR THE KODAK DIRECTVIEW CR MAMMOGRAPHY FEATURE TOGETHER WITH KODAK DIRECTVIEW CR MAMMOGRAPHY CASSETTE COMPRISE A DEVICE WHICH, WHEN USED IN CONJUNCTION WITH A KODAK DIRECTVIEW CR SYSTEM AND A MAMMOGRAPHIC X-RAY MACHINE, GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. IT IS INTENDED FOR USE IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL SCREEN-FILM BASED MAMMOGRAPHIC SYSTEMS. THE MAMMOGRAPHIC IMAGES CAN BE INTERPRETED BY A QUALIFIED PHYSICIAN USING EITHER HARDCOPY FILM OR SOFTCOPY DISPLAY AT A WORKSTATION. |
| 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 |
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|
