|
Device | SIEMENS MAMMOMAT NOVATION FFDM SYSTEM |
Generic Name | Full field digital, system, x-ray, mammographic |
Regulation Number | 892.1715 |
Applicant | SIEMENS MEDICAL SOLUTION 51 VALLEY STREAM PKWY. MALVERN, PA 19355 |
PMA Number | P030010 |
Supplement Number | S001 |
Date Received | 01/19/2005 |
Decision Date | 07/07/2005 |
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 TO CHANGE THE ACQUISITION WORKSTATION (AWS) FROM THE CURRENTLY APPROVED UNIX-BASED SUN WORKSTATION WITH SOLARIS 8 OPERATING SYSTEM TO A FUJITSU/SIEMENS M420PC WITH SYNGO OPERATING SYSTEM AND THE PROPOSED CHANGES ALLOWING THE SOFTWARE DRIVERS FOR THE DETECTOR INTERFACE (DRUL) TO BE WINDOWS XP BASED. |