SENOGRAPHE

Full Field Digital, System, X-ray, Mammographic

FDA Premarket Approval P990066 S015

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 modifications to the approved system to permit use of an optional contrast enhancement algorithm (dynamic range management) introduction of new display protocols and minor changes in the display scenarios, and addition of keyboard shortcuts for window width/window level settings. The supplement also includes changes in the labeling to reflect the modifications listed above.

DeviceSENOGRAPHE
Classification NameFull Field Digital, System, X-ray, Mammographic
Generic NameFull Field Digital, System, X-ray, Mammographic
ApplicantGE Healthcare
Date Received2002-10-03
Decision Date2002-11-21
PMAP990066
SupplementS015
Product CodeMUE
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address GE Healthcare 3000 N. Grandview Blvd waukesha, WI 53188

Supplemental Filings

Supplement NumberDateSupplement Type
P990066Original Filing
S037 2010-06-22 135 Review Track For 30-day Notice
S036 2010-04-27 30-day Notice
S035 2010-01-14 Normal 180 Day Track
S034 2009-10-13 Real-time Process
S033 2009-05-21 Real-time Process
S032 2008-06-30 Special (immediate Track)
S031 2008-06-23 30-day Notice
S030 2008-03-26 Real-time Process
S029 2007-05-21 Real-time Process
S028 2007-02-21 Real-time Process
S027 2006-12-11 Real-time Process
S026 2006-12-01 Special (immediate Track)
S025 2006-09-27 30-day Notice
S024 2006-08-02 Special (immediate Track)
S023 2006-04-17 Special (immediate Track)
S022 2005-09-13 Special (immediate Track)
S021 2005-06-01 Normal 180 Day Track
S020 2005-05-03 Normal 180 Day Track
S019 2005-04-18 Real-time Process
S018
S017 2004-04-12 Normal 180 Day Track No User Fee
S016 2003-09-02 Normal 180 Day Track
S015 2002-10-03 Normal 180 Day Track
S014 2002-06-03 Normal 180 Day Track
S013 2002-05-13 30-day Notice
S012 2002-03-12 30-day Notice
S011 2002-02-07 30-day Notice
S010 2001-11-16 Normal 180 Day Track
S009 2001-11-14 135 Review Track For 30-day Notice
S008 2001-10-26 Real-time Process
S007 2001-10-15 Normal 180 Day Track
S006 2001-09-04 30-day Notice
S005 2001-08-13 30-day Notice
S004 2001-06-08 Normal 180 Day Track
S003 2001-04-04 Normal 180 Day Track
S002 2000-12-19 Normal 180 Day Track
S001 2000-07-28 Normal 180 Day Track

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