PMA P990066S004
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S004
- Product code
- MUE
- Decision date
- 2001-12-06
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR CHANGES TO THE IMAGE CHAIN SOFTWARE, SPECIFICALLY THE AUTOMATIC OPERATING PARAMETERS (AOP) AND THE AUTO-CONTRAST AND THICKNESS COMPENSATION ALGORITHMS; THE ADDITION OF SOME NEW FEATURES TO THE ACQUISITION WORK STATION AND THE REVIEW WORK STATION THAT PROVIDE MORE OPTIONS FOR IMAGE DISPLAY AND PRINTING; AND REVISED LABELING TO ADDRESS THE CHANGES.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S004
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2001-12-06
- Decision code
- APPR
- Date received
- 2001-06-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO THE IMAGE CHAIN SOFTWARE, SPECIFICALLY THE AUTOMATIC OPERATING PARAMETERS (AOP) AND THE AUTO-CONTRAST AND THICKNESS COMPENSATION ALGORITHMS; THE ADDITION OF SOME NEW FEATURES TO THE ACQUISITION WORK STATION AND THE REVIEW WORK STATION THAT PROVIDE MORE OPTIONS FOR IMAGE DISPLAY AND PRINTING; AND REVISED LABELING TO ADDRESS THE CHANGES.