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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K072079
Device Name IGUIDE SYSTEM
Applicant
MEDICAL INTELLIGENCE MEDIZINTECHNIK-GMBH-AN ELEKTA
FEYERABENDSTRASSE 13-15
SCHWABMUNCHEN,  DE 86830
Applicant Contact MICHAEL WOLFF
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/30/2007
Decision Date 08/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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