SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S004 · decided 2001-12-06
Approval details
- PMA number
- P990066
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2001-06-08
- Decision date
- 2001-12-06
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- 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.
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