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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 K120789
Device Name EXACTRAC X-RAY X-RAY
Applicant
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Applicant Contact ALEXANDER SCHWIERSCH
Correspondent
BRAINLAB AG
KAPELLENSTRASSE 12
FELDKIRCHEN,  DE 85622
Correspondent Contact ALEXANDER SCHWIERSCH
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/15/2012
Decision Date 08/14/2012
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
Recalls CDRH Recalls
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