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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 K110919
Device Name CARESTREAM PACS
Applicant
CARESTREAM HEALTH, INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Applicant Contact LINDA STEWART
Correspondent
CARESTREAM HEALTH, INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Correspondent Contact LINDA STEWART
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/01/2011
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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