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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 NameKODAK MAMMOGRAPHY CAD ENGINE
Classification Nameanalyzer,medical image
Generic Nameanalyzer, medical image
ApplicantCARESTREAM HEALTH,INC.
PMA NumberP030007
Date Received03/31/2003
Decision Date11/23/2004
Withdrawal Date 11/13/2012
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 05M-0087
Notice Date 03/09/2005
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the kodak mammography cad engine. The kodak mammography cad engine is a software package 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 software assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.
Approval Order Approval Order
Supplements: S001 S003 
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