GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S035 · decided 2010-05-20
Approval details
- PMA number
- P990066
- Supplement
- S035
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GE HEALTHCARE SENOGRAPHE ESSENTIAL DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2010-01-14
- Decision date
- 2010-05-20
- Days to decision
- 126 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR A MODIFICATION TO THE AMORPHOUS SILICON ARRAY DESIGN USED IN THE DETECTOR OF THE SENOGRAPHE ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THE PROPOSED MODIFICATIONS INCLUDE THE FOLLOWING: 1) REDUCING THE NUMBER OF LAYERS IN THE DETECTOR AMORPHOUS SILICON ARRAY; 2) CHANGE IN THE DETECTOR FIRMWARE TO ALLOW THE DETECTOR CONFIGURATION TO BE COMMUNICATED TO THE SYSTEM IMAGE DETECTOR CONTROLLER (IDC); 3) IDC SOFTWARE TO AUTOMATICALLY DETERMINE IS A DETECTOR WITH THE PROPOSED MODIFICATI
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