FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE
FDA premarket approval P050014/S001 · decided 2009-01-09
Approval details
- PMA number
- P050014
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Fujifilm Medical System U.S.A., Inc.
- Date received
- 2008-10-28
- Decision date
- 2009-01-09
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Stamford, CT
- 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 E
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