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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K022789
Device Name VIATRONIX V3D EXPLORER
Applicant
VIATRONIX, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE PARK,  NC  27709
Applicant Contact JEFF D RONGERO
Correspondent
UNDERWRITERS LABORATORIES, INC.
12 LABORATORY DR.
RESEARCH TRIANGLE,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/22/2002
Decision Date 09/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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