PMA P990066S013
- Device
- GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S013
- Product code
- MUE
- Decision date
- 2002-06-05
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- ADDITION OF A SIEMENS MODEL 6GF6300-1BW04 AWS MONITOR WITH PDS CRT AS AN ALTERNATIVE SUPPLIER OF THE AWS MONITOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM AND SUPPRESSION OF THE AWS MONITOR CALIBRATION TEST.
Current openFDA PMA Record#
- Device
- GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S013
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2002-06-05
- Decision code
- OK30
- Date received
- 2002-05-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SIEMENS MODEL 6GF6300-1BW04 AWS MONITOR WITH PDS CRT AS AN ALTERNATIVE SUPPLIER OF THE AWS MONITOR COMPONENT OF THE GENERAL ELECTRIC MEDICAL SYSTEMS (GEMS) SENOGRAPHE 2000D FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) X-RAY SYSTEM AND SUPPRESSION OF THE AWS MONITOR CALIBRATION TEST.