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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name couch, radiation therapy, powered
510(k) Number K120520
Device Name EXACTRAC ROBOTICS NOVALIS ROBOTICS
Original Applicant
BRAINLAB AG
kapellenstrasse 12
feldkirchen,  GM 85622
Original Contact alexander schwiersch
Regulation Number892.5770
Classification Product Code
JAI  
Date Received02/21/2012
Decision Date 06/29/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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