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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 K231897
Device Name NeuroAlign software
Applicant
Medivis, Inc.
920 Broadway, 16th Floor
New York,  NY  10010
Applicant Contact Amy Lynn
Correspondent
Medivis, Inc.
920 Broadway, 16th Floor
New York,  NY  10010
Correspondent Contact Amy Lynn
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/28/2023
Decision Date 10/21/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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