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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 DIRECTVIEW CR MAMMOGRAPHY FEATURE
Generic NameFull field digital, system, x-ray, mammographic
Regulation Number892.1715
ApplicantCarestream Health, Inc.
150 Verona St.
Rochester, NY 14608
PMA NumberP080018
Supplement NumberS001
Date Received11/03/2010
Decision Date12/01/2010
Reclassified Date12/06/2010
Product Code MUE 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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