SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S019 · decided 2005-05-25
Approval details
- PMA number
- P990066
- Supplement
- S019
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2005-04-18
- Decision date
- 2005-05-25
- Days to decision
- 37 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR CHANGES IN TWO SOFTWARE MODIFICATIONS THAT HAVE BEEN MADE TO THE ACQUISITION WORKSTATION (AWS) AND FOR AN ADDITIONAL SUPPLIER FOR THE CONDITIONER (CHILLER FOR THE IMAGE RECEPTOR). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM AND IS INDICATED AS FOLLOWS: THE SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM GENERATES DIGITAL MAMMOGRAPHIC IMAGES THAT CAN BE USED FOR SCREENING AND DIAGNOSIS OF BREAST CANCER. THE SE
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