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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K072191
Device Name CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM
Applicant
Gvi Technology Partners
1470 Enterprise Pkwy.
Twinsburg,  OH  44087
Applicant Contact KEVIN M MURROCK
Correspondent
Gvi Technology Partners
1470 Enterprise Pkwy.
Twinsburg,  OH  44087
Correspondent Contact KEVIN M MURROCK
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/06/2007
Decision Date 10/25/2007
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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