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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 K112096
Device Name IMAGELINK
Applicant
Computer Programs and Systems, Inc.
6600 Wall St.
Mobile,  AL  36695 -4512
Applicant Contact MICHAEL HUNT
Correspondent
Computer Programs and Systems, Inc.
6600 Wall St.
Mobile,  AL  36695 -4512
Correspondent Contact MICHAEL HUNT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/22/2011
Decision Date 09/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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