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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 K152279
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 Received08/12/2015
Decision Date 09/10/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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