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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 K994413
Device Name BRAINSCAN
Original Applicant
BRAINLAB AG
ammerthalstrasse 8
heimstetten,  GM 85551
Original Contact stefan vilsmeier
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/29/1999
Decision Date 07/13/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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