SIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM

FDA Premarket Approval P030010 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceSIEMENS MAMMOMAT INSPIRATION FULL - FIELD DIGITAL MAMMOGRAPHY SYSTEM
Generic NameFull Field Digital, System, X-ray, Mammographic
ApplicantSIEMENS MEDICAL SOLUTION
Date Received2009-10-13
Decision Date2010-11-05
PMAP030010
SupplementS006
Product CodeMUE 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address SIEMENS MEDICAL SOLUTION 51 Valley Stream Pkwy. malvern, PA 19355

Supplemental Filings

Supplement NumberDateSupplement Type
P030010Original Filing
S006 2009-10-13 Normal 180 Day Track
S005 2009-07-22 Normal 180 Day Track
S004 2009-05-18 Special (immediate Track)
S003 2005-10-26 Real-time Process
S002 2005-05-20 Special (immediate Track)
S001 2005-01-19 Normal 180 Day Track

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.