IMAGECHECKER M1000

FDA Premarket Approval P970058 S012

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 a change to the new efficacy claim in pma supplement 7 (version 2. 2 software). The change is from: "for every 100,000 cancers currently detected by screening mammography, the use of the imagechecker could result in early detection of an additional 30,500 breast cancers. " to: "use of the imagechecker could result in earlier detection of up to 23. 4% (95% ci, 19. 4% - 27. 4%) of the cancers currently detected with screening mammography in those women who had a prior screening mammogram 9-24 months earlier. "

DeviceIMAGECHECKER M1000
Generic NameAnalyzer, Medical Image
ApplicantHOLOGIC, INC.
Date Received2002-02-05
Decision Date2002-02-11
PMAP970058
SupplementS012
Product CodeMYN 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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
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