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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 K060903
Device Name IG4 IMAGE GUIDED SYSTEM
Applicant
VERAN MEDICAL TECHNOLOGIES, INC.
2409 21ST AVENUE SOUTH
SUITE 205
NASHVILLE,  TN  37212
Applicant Contact TORSTEN M LYON
Correspondent
VERAN MEDICAL TECHNOLOGIES, INC.
2409 21ST AVENUE SOUTH
SUITE 205
NASHVILLE,  TN  37212
Correspondent Contact TORSTEN M LYON
Regulation Number892.1750
Classification Product Code
JAK  
Date Received04/03/2006
Decision Date 05/11/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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