PMA P990066S033
- Device
- GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S033
- Product code
- MUE
- Decision date
- 2009-07-10
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE SENOGRAPHE DS AND SENOGRAPHE ESSENTIAL FFDM SYSTEMS THAT WILL REMOVE BOTH MAGNIFICATION STANDS AND CORRESPONDING MAGNIFICATION COMPRESSION PADDLES FOR BOTH SYSTEMS. THE COMPONENTS THAT ARE PROPOSED FOR REMOVAL FROM THE CONFIGURATION WILL STILL BE AVAILABLE TO THE CUSTOMER AS OPTIONAL EQUIPMENT.
Current openFDA PMA Record#
- Device
- GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S033
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2009-07-10
- Decision code
- APPR
- Date received
- 2009-05-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE SENOGRAPHE DS AND SENOGRAPHE ESSENTIAL FFDM SYSTEMS THAT WILL REMOVE BOTH MAGNIFICATION STANDS AND CORRESPONDING MAGNIFICATION COMPRESSION PADDLES FOR BOTH SYSTEMS. THE COMPONENTS THAT ARE PROPOSED FOR REMOVAL FROM THE CONFIGURATION WILL STILL BE AVAILABLE TO THE CUSTOMER AS OPTIONAL EQUIPMENT.