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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 K073194
Device Name CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS
Applicant
Cardiovascular Imaging Solutions , Ltd.
1600 Manchester Way
Denton,  TX  76210
Applicant Contact CARL THOMAS
Correspondent
Cardiovascular Imaging Solutions , Ltd.
1600 Manchester Way
Denton,  TX  76210
Correspondent Contact CARL THOMAS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/13/2007
Decision Date 02/14/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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