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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K053584
Device Name IPLAN RT DOSE
Applicant
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Applicant Contact RAINER BIRKENBACH
Correspondent
Brainlab AG
Ammerthalstrasse 8
Heimstetten,  DE 85551
Correspondent Contact RAINER BIRKENBACH
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/23/2005
Decision Date 07/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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