PMA P990066S016
- Device
- SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S016
- Product code
- MUE
- Decision date
- 2004-02-19
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR CHANGES IN ERGONOMICS, THE IMAGE ACQUISITION CHAIN, IMAGE PRESENTATION ON THE AWS, AND CONNECTIVITY. IN ADDITION THE APPLICATION REQUESTED ADDITIONAL IMAGE QUALITY CLAIMS AND QC MANUAL CHANGES FOR QC TEST TECHNIQUE FACTORS AND PROCEDURES UNDER MQSA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S016
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2004-02-19
- Decision code
- APPR
- Date received
- 2003-09-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES IN ERGONOMICS, THE IMAGE ACQUISITION CHAIN, IMAGE PRESENTATION ON THE AWS, AND CONNECTIVITY. IN ADDITION THE APPLICATION REQUESTED ADDITIONAL IMAGE QUALITY CLAIMS AND QC MANUAL CHANGES FOR QC TEST TECHNIQUE FACTORS AND PROCEDURES UNDER MQSA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.