PMA P990066S010
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S010
- Product code
- MUE
- Decision date
- 2001-12-03
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR A MODIFIED CONTROL CONSOLE INCLUDING MINOR HARDWARE AND SOFTWARE MODIFICATIONS TO THE APPROVED SYSTEM. THE SUPPLEMENT ALSO INCLUDES APPROPRIATE CHANGES IN THE LABELING TO REFLECT THESE CHANGES.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S010
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2001-12-03
- Decision code
- APPR
- Date received
- 2001-11-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFIED CONTROL CONSOLE INCLUDING MINOR HARDWARE AND SOFTWARE MODIFICATIONS TO THE APPROVED SYSTEM. THE SUPPLEMENT ALSO INCLUDES APPROPRIATE CHANGES IN THE LABELING TO REFLECT THESE CHANGES.