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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, Tomography, Computed
510(k) Number K083293
Device Name VIATRONIX V3D-CARDIAC, REVISION 1.0
Applicant
Viatronix, Inc.
25 Health Sciences Dr.
Suite 203/204
Stony Brook,  NY  11790
Applicant Contact DONGQING CHEN
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/10/2008
Decision Date 12/05/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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