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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K170816
Device Name Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM
Applicant
Brainlab AG
Olof-Palme-Str. 9
Munchen,  DE 81829
Applicant Contact Rainer Birkenbach
Correspondent
Brainlab AG
Olof-Palme-Str. 9
Munchen,  DE 81829
Correspondent Contact Alexander Schwiersch
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
JAK  
Date Received03/20/2017
Decision Date 09/26/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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