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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 K934657
Device Name BRAINLAB LINAC HARDWARE
Applicant
Brainlab Med. Computersysteme GmbH
120 Defreest Srive
Troy,  NY  12180
Applicant Contact STEFAN VILSMEIER
Correspondent
Brainlab Med. Computersysteme GmbH
120 Defreest Srive
Troy,  NY  12180
Correspondent Contact STEFAN VILSMEIER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/21/1993
Decision Date 07/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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