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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 K041448
Device Name HEXAPOD RT COUCHTOP
Applicant
Medical Intelligence Medizintechnik GmbH
Feyerabendstrasse 13-15
Schwabmunchen,  DE 86830
Applicant Contact SANDOR CSABA ATS
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Regulation Number892.5770
Classification Product Code
JAI  
Date Received06/01/2004
Decision Date 06/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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