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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceKODAK MAMMOGRAPHY CAD ENGINE
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantCarestream Health, Inc.
150 Verona St.
Rochester, NY 14608
PMA NumberP030007
Supplement NumberS003
Date Received02/28/2007
Decision Date03/23/2007
Withdrawal Date11/13/2012
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT EASTMAN KODAK COMPANY, ROCHESTER, NEW YORK. THIS IS ASOFTWARE MANUFACTURING LOCATION CHANGE THAT CONSISTS OF A SERVER MOVE FROM SAN JOSE, CALIFORNIA TO ROCHESTER, NEW YORK.
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