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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(K) Number K122523
Model CARESTREAM VUE PACS V11.3.2.4
Device Name CARESTREAM VUE PACS
Applicant
CARESTREAM HEALTH, INC.
150 verona street
rochester,  NY  14608
Contact alexandra chamberlain
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/20/2012
Decision Date 10/23/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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