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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K102123
Device Name VIZION DR
Applicant
Viztek, Inc.
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
Viztek, Inc.
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received07/29/2010
Decision Date 01/24/2011
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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