PMA P030010

Device: SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Siemens Medical Solution
PMA number: P030010
Supplement: S006
Product code: MUE
Decision date: 2010-11-05
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL FOR CHANGING THE OEM COMPONENTS (DETECTOR AND IMAGE PROCESSING) DEVELOPED BY LORAD, THE MAMMOMAT NOVATION, TO AN FFDM SYSTEM THAT IS DESIGNED SOLELY FROM COMPONENTS DESIGNED OR SPECIFIED BY SIEMENS, THE MAMMOMAT INSPIRATION.

Current openFDA PMA Record#

Device: SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Siemens Medical Solution
PMA number: P030010
Supplement: S006
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2010-11-05
Decision code: APPR
Date received: 2009-10-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR CHANGING THE OEM COMPONENTS (DETECTOR AND IMAGE PROCESSING) DEVELOPED BY LORAD, THE MAMMOMAT NOVATION, TO AN FFDM SYSTEM THAT IS DESIGNED SOLELY FROM COMPONENTS DESIGNED OR SPECIFIED BY SIEMENS, THE MAMMOMAT INSPIRATION.