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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameIMAGE CHECKER (CAD) SYSTEM, M1000
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantR2 TECHNOLOGY, INC.
PMA NumberP970058
Supplement NumberS010
Date Received04/19/2001
Decision Date05/29/2001
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the expansion of the indications for use to cover diagnostic as well as screening mammograms. The new indications for use is: the imagechecker m1000 is a computer system intended to identify and mark regions of interest on routine screening and diagnostic mammograms to bring them to the attention of the radiologist after the initial reading has 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.
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