Full Field Digital, System, X-Ray, Mammographic
Basic Information
- Device Name
- Full Field Digital, System, X-Ray, Mammographic
- Trade Name
- FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE
- PMA Number
- P050014
- Supplement Number
- S001
- Device Class
- FDA Class 2
- Product Code
- MUE
- Generic Name
- Full field digital, system, x-ray, mammographic
- Regulation Number
- 892.1715
- Medical Specialty
- Radiology
- Advisory Committee
- Radiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 9, 2009
- Date Received
- October 28, 2008
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MUE | Full Field Digital, System, X-Ray, Mammographic | FDA class 2 | Radiology |