|
Device | GE HEALTHCARE SENOGRAPHE 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 | S034 |
Date Received | 10/13/2009 |
Decision Date | 11/24/2009 |
Reclassified Date
|
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 A MODIFICATION TO THE SENOGRAPHE DS AND SENOGRAPHE ESSENTIAL FFDM SYSTEMS THAT WILL REMOVE BOTH MAGNIFICATION STANDS, AND CORRESPONDING MAGNIFICATION COMPRESSION PADDLES FOR BOTH SYSTEMS. THE COMPONENTS THAT ARE REMOVED FROM THE CONFIGURATION WILL STILL BE AVAILABLE TO THE CUSTOMER AS OPTIONAL EQUIPMENT. |