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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.
Classification Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
PMA NumberP080018
Supplement NumberS001
Date Received11/03/2010
Decision Date12/01/2010
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the kodak directview cr mammography system. 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 hard copy film or soft copy display at a workstation.