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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 K093146
Device Name IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200
Applicant
VERAN MEDICAL TECHNOLOGIES, INC.
5743 WEST PARK AVE
ST. LOUIS,  MO  63110
Applicant Contact SCOTT WRIGHTSTONE
Correspondent
VERAN MEDICAL TECHNOLOGIES, INC.
5743 WEST PARK AVE
ST. LOUIS,  MO  63110
Correspondent Contact SCOTT WRIGHTSTONE
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/05/2009
Decision Date 11/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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