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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, real-time intraoperative mri
510(k) Number K181195
Device Name ClearPoint System
MRI Interventions, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact Pete Piferi
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number882.4560
Classification Product Code
Subsequent Product Code
Date Received05/04/2018
Decision Date 11/02/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No