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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K170750
Device Name RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Applicant
Brainlab AG
Olof-Palme-Str 9
Munich,  DE 81829
Applicant Contact Rainer Birkenbach
Correspondent
Brainlab AG
Olof-Palme-Str 9
Munich,  DE 81829
Correspondent Contact Alexander Schwiersch
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/13/2017
Decision Date 08/24/2017
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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