PMA P990066S021
- Device
- SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S021
- Product code
- MUE
- Decision date
- 2006-04-11
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM WITH INCREASED DETECTOR AREA TO ACCOMMODATE A LARGER RANGE OF BREAST SIZES FOR THE PURPOSE OF SCREENING AND DIAGNOSIS.
Current openFDA PMA Record#
- Device
- SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S021
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2006-04-11
- Decision code
- APPR
- Date received
- 2005-06-01
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM WITH INCREASED DETECTOR AREA TO ACCOMMODATE A LARGER RANGE OF BREAST SIZES FOR THE PURPOSE OF SCREENING AND DIAGNOSIS.