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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K103782
Device Name 4D MV-ASSESSMENT 2.0
Applicant
Tomtec Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE D-85716
Applicant Contact INGE SCHEIDT
Correspondent
Tomtec Imaging Systems GmbH
Edisonstrasse 6
Unterschleissheim,  DE D-85716
Correspondent Contact INGE SCHEIDT
Regulation Number870.1425
Classification Product Code
DQK  
Date Received12/27/2010
Decision Date 01/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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