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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 NameIMAGECHECKER CAD SYSTEM FOR MAMMOGRAPHY
Classification Nameanalyzer,medical image
Generic Nameimage analysis system
ApplicantR2 TECHNOLOGY, INC.
PMA NumberP970058
Supplement NumberS022
Date Received02/01/2006
Decision Date06/23/2006
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of new labeling that will present the specificity of cad marks generated by r2 imagechecker computer aided detection system as well as its ability to mark actionable priors. The indications for use remain as previously approved: the imagechecker m5000 is a computer system intended to identify and mark regions of interest on routine screening 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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