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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K111566
Device Name DRYVIEW CHROMA IMAGING SYSTEM
Applicant
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Applicant Contact CHRISTINE EHAMNN
Correspondent
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Correspondent Contact CHRISTINE EHAMNN
Regulation Number892.2040
Classification Product Code
LMC  
Date Received06/06/2011
Decision Date 10/06/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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