Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
Generic Name | Full field digital, system, x-ray, mammographic |
Regulation Number | 892.1715 |
Applicant | GE Healthcare 3000 N. GRANDVIEW BLVD WAUKESHA, WI 53188 |
PMA Number | P990066 |
Supplement Number | S019 |
Date Received | 04/18/2005 |
Decision Date | 05/25/2005 |
Reclassified Date
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12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 SENOGRAPHE DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM IS INTENDED TO BE USED IN THE SAME CLINICAL APPLICATIONS AS TRADITIONAL FILM-BASED MAMMOGRAPHIC SYSTEM. |
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