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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K163203
Device Name Carestream DRX-Evolution
Applicant
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Applicant Contact Carolyn L. Wagner
Correspondent
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Correspondent Contact Carolyn L. Wagner
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/15/2016
Decision Date 12/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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