PMA P030010S001

Device: SIEMENS MAMMOMAT NOVATION FFDM SYSTEM
Applicant: Siemens Medical Solution
PMA number: P030010
Supplement: S001
Product code: MUE
Decision date: 2005-07-07
Generic name: Full field digital, system, x-ray, mammographic
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.

Current openFDA PMA Record#

Device: SIEMENS MAMMOMAT NOVATION FFDM SYSTEM
Applicant: Siemens Medical Solution
PMA number: P030010
Supplement: S001
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2005-07-07
Decision code: APPR
Date received: 2005-01-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.