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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Scintillation (Gamma)
510(k) Number K051402
Device Name ONEPASS 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 Number892.1100
Classification Product Code
IYX  
Date Received05/31/2005
Decision Date 06/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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