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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 K053281
Device Name EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
Applicant
EMAGEON INC.
10 WEST MIFFLIN ST.
SUITE 400
MADISON,  WI  53704
Applicant Contact INGER L HANSON
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact PEDROT GONZALEZ
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/25/2005
Decision Date 12/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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