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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K223288
Device Name Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Applicant
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Applicant Contact Esther Moreno Garcia
Correspondent
Brainlab AG
Olof-Palme-Str. 9
Munich,  DE 81829
Correspondent Contact Esther Moreno Garcia
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/25/2022
Decision Date 07/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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