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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 K020860
Device Name M3 (MICRO-MULTILEAF COLLIMATOR)
Applicant
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Applicant Contact STEFAN VILSMEIER
Correspondent
BRAINLAB AG
AMMERTHALSTRASSE 8
HEIMSTETTEN,  DE 85551
Correspondent Contact STEFAN VILSMEIER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/18/2002
Decision Date 06/06/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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