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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 K003285
Device Name EXAC TRAC 2.0 (NOVALIS BODY MODULE)
Original Applicant
BRAINLAB, AG
ammerthalstrasse 8
heimstetten,  DE 85551
Original Contact stefan vilsmelier
Regulation Number892.5050
Classification Product Code
IYE  
Date Received10/19/2000
Decision Date 07/31/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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