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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name automated radiological image processing software
510(k) Number K213645
Device Name ClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact Pete Piferi
Hogan Lovells US LPP
555 Thirteenth St, NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
Date Received11/18/2021
Decision Date 08/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No