PMA P990066S015
- Device
- SENOGRAPHE
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S015
- Product code
- MUE
- Decision date
- 2002-11-21
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order 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.
Current openFDA PMA Record#
- Device
- SENOGRAPHE
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S015
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2002-11-21
- Decision code
- APPR
- Date received
- 2002-10-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.