- Device
- SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM
- Applicant
- Siemens Medical Solution
- PMA number
- P030010
- Supplement
- S005
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2010-10-06
- Decision code
- APPR
- Date received
- 2009-07-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SIEMENS OWN IMAGE PROCESSING ALGORITHMS ON THE MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM.