SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S021 · decided 2006-04-11
Approval details
- PMA number
- P990066
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Trade name
- SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2005-06-01
- Decision date
- 2006-04-11
- Days to decision
- 314 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- 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.
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