PMA P990066S028
- Device
- SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S028
- Product code
- MUE
- Decision date
- 2007-04-13
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR 1) A NEW COMPUTER; 2) MODIFICATION OF THE SOFTWARE; 3) ADDITION OF A THIRD PARTY SOFTWARE PROGRAM; 4) CHANGES IN THE PROPRIETARY SOFTWARE; AND 5) REPLACEMENT OF THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WITH A SMALLER TYPE.
Current openFDA PMA Record#
- Device
- SENOGRAPHE DS AND ESSENTIAL FULL FIELD MAMMOGRAPHY SYSTEMS
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S028
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2007-04-13
- Decision code
- APPR
- Date received
- 2007-02-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1) A NEW COMPUTER; 2) MODIFICATION OF THE SOFTWARE; 3) ADDITION OF A THIRD PARTY SOFTWARE PROGRAM; 4) CHANGES IN THE PROPRIETARY SOFTWARE; AND 5) REPLACEMENT OF THE UNINTERRUPTIBLE POWER SUPPLY (UPS) WITH A SMALLER TYPE.