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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 K171257
Device Name ClearPoint System
Applicant
MRI Interventions, Inc.
5 Musick
Irvine,  CA  92618
Applicant Contact Pete Piferi
Correspondent
Hogan Lovells US LLP
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith,
Regulation Number882.4560
Classification Product Code
ORR  
Subsequent Product Code
HAW  
Date Received04/28/2017
Decision Date 10/20/2017
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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