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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 K100094
Device Name CARESTREAM IMAGE SUITE
Applicant
CARESTREAM HEATLH, INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Applicant Contact JOHN PARDO
Correspondent
CARESTREAM HEATLH, INC.
150 VERONA STREET
ROCHESTER,  NY  14608
Correspondent Contact JOHN PARDO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/13/2010
Decision Date 03/11/2010
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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