|
Device | SENOGRAPHE DS & 2000D 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 | S020 |
Date Received | 05/03/2005 |
Decision Date | 07/01/2005 |
Reclassified Date
|
12/06/2010 |
Product Code |
MUE |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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. |