SENOGRAPHE
FDA premarket approval P990066/S015 · decided 2002-11-21
Approval details
- PMA number
- P990066
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOGRAPHE
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2002-10-03
- Decision date
- 2002-11-21
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR MODIFICATIONS TO THE APPROVED SYSTEM TO PERMIT USE OF AN OPTIONAL CONTRAST ENHANCEMENT ALGORITHM (DYNAMIC RANGE MANAGEMENT) INTRODUCTION OF NEW DISPLAY PROTOCOLS AND MINOR CHANGES IN THE DISPLAY SCENARIOS, AND ADDITION OF KEYBOARD SHORTCUTS FOR WINDOW WIDTH/WINDOW LEVEL SETTINGS. THE SUPPLEMENT ALSO INCLUDES CHANGES IN THE LABELING TO REFLECT THE MODIFICATIONS LISTED ABOVE.
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