M1000 IMAGECHECKER

FDA Premarket Approval P970058

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

The image checker m1000 is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them tot he attention of the radiologist after the initial readin ghas been completed. Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

DeviceM1000 IMAGECHECKER
Generic NameAnalyzer, Medical Image
ApplicantHOLOGIC, INC.
Date Received1997-12-16
Decision Date1998-06-26
Notice Date1998-08-12
PMAP970058
SupplementS
Product CodeMYN 
Docket Number98M-0618
Advisory CommitteeRadiology
Expedited ReviewNo
Combination Product No
Applicant Address HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P970058Original Filing
S027 2016-01-20 Normal 180 Day Track No User Fee
S026 2013-10-17 Normal 180 Day Track
S025 2012-02-06 Normal 180 Day Track
S024 2006-09-18 Normal 180 Day Track No User Fee
S023
S022 2005-11-28 Normal 180 Day Track
S021 2004-11-19 Real-time Process
S020 2004-06-29 Normal 180 Day Track
S019 2004-03-01 Real-time Process
S018 2003-10-22 Real-time Process
S017 2003-07-08 Normal 180 Day Track
S016 2003-05-08 Normal 180 Day Track
S015 2002-10-22 Normal 180 Day Track
S014 2002-07-15 Normal 180 Day Track
S013 2002-02-19 Real-time Process
S012 2002-02-05 Normal 180 Day Track
S011 2001-09-28 Normal 180 Day Track
S010 2001-04-19 Normal 180 Day Track
S009 2000-12-08 Normal 180 Day Track
S008 2000-06-01 Normal 180 Day Track
S007 2000-01-28 Normal 180 Day Track
S006 2000-01-14 Normal 180 Day Track
S005 1999-09-08 Real-time Process
S004 1999-06-21 Normal 180 Day Track
S003 1998-12-16 Normal 180 Day Track
S002 1998-10-01 Normal 180 Day Track
S001 1998-09-29 Real-time Process

NIH GUDID Devices

Device IDPMASupp
15420045500037 P970058 026
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.