PMA P990066S020
- Device
- SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S020
- Product code
- MUE
- Decision date
- 2005-07-01
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE SENOGRAPHE DS AND (2000D) FFDM ACQUITION WORKSTATION (AWS) AND REVIEW WORKSTATION TO ALLOW USERS TO SELECT THE PREMIUM VIEW (PV) ALGORITHM AS PRIMARY IMAGE PROCESSING.
Current openFDA PMA Record#
- Device
- SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S020
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2005-07-01
- Decision code
- APPR
- Date received
- 2005-05-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE SENOGRAPHE DS AND (2000D) FFDM ACQUITION WORKSTATION (AWS) AND REVIEW WORKSTATION TO ALLOW USERS TO SELECT THE PREMIUM VIEW (PV) ALGORITHM AS PRIMARY IMAGE PROCESSING.