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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 K232759
Device Name Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout
Applicant
Brainlab AG
Olof-Palme-StraBe 9
Münich,  DE 81829
Applicant Contact Sadwini Suresh
Correspondent
Brainlab AG
Olof-Palme-StraBe 9
Münich,  DE 81829
Correspondent Contact Sadwini Suresh
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/08/2023
Decision Date 05/21/2024
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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