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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 K190664
Device Name RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review
Brainlab AG
Olof-Palme-Str. 9
München,  DE 81829
Applicant Contact Rainer Birkenbach
Brainlab AG
Olof-Palme-Str. 9
München,  DE 81829
Correspondent Contact Alexander Schwiersch
Regulation Number892.5050
Classification Product Code
Date Received03/15/2019
Decision Date 04/12/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No