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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 K153103
Device Name CARESTREAM Vue PACS
Applicant
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14468
Applicant Contact Diane Koetter
Correspondent
Carestream Health, Inc.
150 Verona St.
Rochester,  NY  14608
Correspondent Contact Diane Koetter
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/26/2015
Decision Date 02/12/2016
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
Recalls CDRH Recalls
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