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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameM1000 IMAGECHECKER
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantHOLOGIC, INC.
PMA NumberP970058
Date Received12/16/1997
Decision Date06/26/1998
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 98M-0618
Notice Date 08/12/1998
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S024 S025 S026 
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