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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 K132824
Device Name CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION
Applicant
CARESTREAM HEALTH,INC.
8708 CAPEHART COVE
AUSTIN,  TX  78733
Applicant Contact DAVID C FURR
Correspondent
CARESTREAM HEALTH,INC.
8708 CAPEHART COVE
AUSTIN,  TX  78733
Correspondent Contact DAVID C FURR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/09/2013
Decision Date 02/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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