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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 K082144
Device Name AMICAS PACS, VERSION 6.0
Applicant
Amicas, Inc.
20 Guest St.
Boston,  MA  02135
Applicant Contact PATRICE JC NEDELEC
Correspondent
Amicas, Inc.
20 Guest St.
Boston,  MA  02135
Correspondent Contact PATRICE JC NEDELEC
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/30/2008
Decision Date 09/05/2008
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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