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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 K160810
Device Name ViZion DR + Wireless
Applicant
Viztek LLC
2217 US HWY 70 East
Garner,  NC  27529
Applicant Contact Bruce Ashby
Correspondent
Kamm & Associates
8870 Ravello Ct
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1680
Classification Product Code
MQB  
Date Received03/24/2016
Decision Date 05/20/2016
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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