- Device
- FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- PMA number
- P050014
- Supplement
- S001
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2009-01-09
- Decision code
- APPR
- Date received
- 2008-10-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.