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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 K042008
Device Name ULTRAVISUAL
Applicant
Emageon Uv, Inc.
131 W. Wilson St., Suite 700
Madison,  WI  53703 -3243
Applicant Contact INGER COUTURE
Correspondent
Tuv America, Inc.
1775 Old Highway 8
New Brighton,  MN  55112 -1891
Correspondent Contact LAURA DANIELSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/26/2004
Decision Date 09/03/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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