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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 DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY
Classification Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
ApplicantCARESTREAM HEALTH, INC.
PMA NumberP080018
Date Received07/28/2008
Decision Date11/03/2010
Reclassified Date 12/06/2010
Product Code
MUE[ Registered Establishments with MUE ]
Docket Number 10M-0591
Notice Date 11/23/2010
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 directview cr mammography system. The device is indicated for the kodak directview cr mammography feature together with kodak directview cr mammography cassette comprise a device which, when used in conjunction with a kodak directview cr system and a mammographic x-ray machine, generates digital mammographic images that can be used for screening and diagnosis of breast cancer. It is intended for use in the same clinical applications as traditional screen-film based mammographic systems. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a workstation.
Approval Order Approval Order
Supplements: S001 
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