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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 K112210
Device Name FRAXION
Applicant
Medical Intelligence Medizintechnik GmbH
Robert-Bosch-Strasse 8
Schwabmuenchen,  DE 86830
Applicant Contact MICHAEL WOLFF
Correspondent
Medical Intelligence Medizintechnik GmbH
Robert-Bosch-Strasse 8
Schwabmuenchen,  DE 86830
Correspondent Contact MICHAEL WOLFF
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/01/2011
Decision Date 11/22/2011
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
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