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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 K073062
Device Name OMNI-VUE SYSTEM
Applicant
GENESIS DIGITAL IMAGING, INC.
1600 MANCHESTER WAY
CORINTH,  TX  76210
Applicant Contact CARL ALLETTO
Correspondent
GENESIS DIGITAL IMAGING, INC.
1600 MANCHESTER WAY
CORINTH,  TX  76210
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/30/2007
Decision Date 03/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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