PMA P990066S030
- Device
- GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S030
- Product code
- MUE
- Decision date
- 2008-05-27
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF AUTOMATIC OPTIMIZATION OF PARAMETERS (AOP) SOFTWARE TO INCREASE CONTRAST TO NOISE RATIO FOR THICKER DENSER BREASTS.
Current openFDA PMA Record#
- Device
- GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S030
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2008-05-27
- Decision code
- APPR
- Date received
- 2008-03-26
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF AUTOMATIC OPTIMIZATION OF PARAMETERS (AOP) SOFTWARE TO INCREASE CONTRAST TO NOISE RATIO FOR THICKER DENSER BREASTS.