PMA P990066S007
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S007
- Product code
- MUE
- Decision date
- 2002-04-12
- 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 SYSTEM TO PERMIT INTEGRATION AND USE OF THE IMAGECHECKER M1000-DM COMPUTER AIDED DETECTION (CAD) SYSTEM MANUFACTURED BY R2 TECHNOLOGY, INC.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S007
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2002-04-12
- Decision code
- APPR
- Date received
- 2001-10-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE SYSTEM TO PERMIT INTEGRATION AND USE OF THE IMAGECHECKER M1000-DM COMPUTER AIDED DETECTION (CAD) SYSTEM MANUFACTURED BY R2 TECHNOLOGY, INC.