SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S020 · decided 2005-07-01
Approval details
- PMA number
- P990066
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOGRAPHE DS & 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2005-05-03
- Decision date
- 2005-07-01
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE SENOGRAPHE DS AND (2000D) FFDM ACQUITION WORKSTATION (AWS) AND REVIEW WORKSTATION TO ALLOW USERS TO SELECT THE PREMIUM VIEW (PV) ALGORITHM AS PRIMARY IMAGE PROCESSING.
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