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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 K040050
Device Name INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500
Applicant
Ge Medical Systems Navigation and Visualization IN
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Applicant Contact JEFF WAGNER
Correspondent
Ge Medical Systems Navigation and Visualization IN
384 Wright Brothers Dr.
Salt Lake City,  UT  84116
Correspondent Contact JEFF WAGNER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/12/2004
Decision Date 03/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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