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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K193324
Device Name Motion Correction System
Applicant
Kineticor, Inc.
3465 Waialae Ave., Suite 300a
Honolulu,  HI  96816
Applicant Contact Doug Donzelli
Correspondent
Kineticor, Inc.
3465 Waialae Ave., Suite 300a
Honolulu,  HI  96816
Correspondent Contact Scott R. Herr
Regulation Number892.1000
Classification Product Code
LNH  
Date Received12/02/2019
Decision Date 02/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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