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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 STREET
MOBILE,  AL  36695 -4512
Applicant Contact MICHAEL HUNT
Correspondent
COMPUTER PROGRAMS AND SYSTEMS, INC.
6600 WALL STREET
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
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