| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE |
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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 | Fujifilm Medical System U.S.A., Inc.
419 W. Ave.
Stamford, CT 06902 |
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| PMA Number | P050014 |
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| Supplement Number | S001 |
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| Date Received | 10/28/2008 |
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| Decision Date | 01/09/2009 |
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| Reclassified Date | 12/06/2010 |
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| Product Code |
MUE |
| Advisory Committee |
Radiology |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR: 1) SOFTWARE VERSION 5.0 WITH 12-BIT OUTPUT ENABLED. CURRENTLY FOR MAMMOGRAPHY,ONLY 10-BIT OUTPUT IS ENABLED SO THIS CHANGE WOULD GIVE THE END USER THE OPTION OF EITHER10-BIT OR 12-BIT OUTPUT FOR MAMMOGRAPHY IMAGES; AND2) LABELING CHANGES MADE TO THE FCRM FUJI CR FOR MAMMOGRAPHY USER GUIDE 1STEDITION JULY, 2006 TO INCLUDE:A) INFORMATION IN CHAPTERS 3 AND 4 WERE REVERSED SO THAT EXPOSURE FACTORS AREDISCUSSED BEFORE AUTOMATIC EXPOSURE CONTROL (AEC) CALIBRATION;B) MORE SPECIFIC X-RAY EXPOSURE INSTRUCTIONS KVP RANGES, AND RECOMMENDED TARGETAND FILTER SELECTION HAVE BEEN ADDED TO HELP FCRM USERS SELECT EXPOSURE SETTINGSBASED ON CONTRAST-TO-NOISE RATIO (CNR); ANDC) INSTRUCTIONS ARE PROVIDED DURING THE SETUP OF THE AEC SYSTEM SO THAT EXPOSURETECHNIQUES WILL BE BASED ON THE X-RAY EXPOSURE SETTINGS RECOMMENDED IN CHAPTER 3. |
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