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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Couch, Radiation Therapy, Powered
510(k) Number K072898
Device Name HEXAPOD EVO RT COUCH TOP
Applicant
Medical Intelligence Medizintechnik GmbH
Robert-Bosch-Strasse 8
Schwabmuenchen,  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 Number892.5770
Classification Product Code
JAI  
Date Received10/11/2007
Decision Date 10/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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