PMA P990066S035
- Device
- GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S035
- Product code
- MUE
- Decision date
- 2010-05-20
- 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 AMORPHOUS SILICON ARRAY DESIGN USED IN THE DETECTOR OF THE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE PROPOSED MODIFICATIONS INCLUDE THE FOLLOWING: 1) REDUCING THE NUMBER OF LAYERS IN THE DETECTOR AMORPHOUS SILICON ARRAY; 2) CHANGE IN THE DETECTOR FIRMWARE TO ALLOW THE DETECTOR CONFIGURATION TO BE COMMUNICATED TO THE SYSTEM IMAGE DETECTOR CONTROLLER (IDC); 3) IDC SOFTWARE TO AUTOMATICALLY DETERMINE IS A DETECTOR WITH THE PROPOSED MODIFICATION IS INSTALLED ON THE SYSTEM AND PROPERLY SELECT THE PROPER CONFIGURATION TABLE; AND 4) CORRESPONDING CHANGES IN THE INCOMING ACCEPTANCE CRITERIA TESTING STATION FOR THE MODIFIED DETECTOR.
Current openFDA PMA Record#
- Device
- GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S035
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2010-05-20
- Decision code
- APPR
- Date received
- 2010-01-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE AMORPHOUS SILICON ARRAY DESIGN USED IN THE DETECTOR OF THE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE PROPOSED MODIFICATIONS INCLUDE THE FOLLOWING: 1) REDUCING THE NUMBER OF LAYERS IN THE DETECTOR AMORPHOUS SILICON ARRAY; 2) CHANGE IN THE DETECTOR FIRMWARE TO ALLOW THE DETECTOR CONFIGURATION TO BE COMMUNICATED TO THE SYSTEM IMAGE DETECTOR CONTROLLER (IDC); 3) IDC SOFTWARE TO AUTOMATICALLY DETERMINE IS A DETECTOR WITH THE PROPOSED MODIFICATION IS INSTALLED ON THE SYSTEM AND PROPERLY SELECT THE PROPER CONFIGURATION TABLE; AND 4) CORRESPONDING CHANGES IN THE INCOMING ACCEPTANCE CRITERIA TESTING STATION FOR THE MODIFIED DETECTOR.