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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K123644
Device Name VIZION + DR
Applicant
Viztek, LLC
8870 Ravello Ct.
Naples,  FL  34114
Applicant Contact DANIEL KAMM, P.E.
Correspondent
Viztek, LLC
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact DANIEL KAMM, P.E.
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/26/2012
Decision Date 01/11/2013
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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