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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 K193102
Device Name MRIaudio PREM System with MRIview
Applicant
Mriaudio, Inc.
5909 Sea Lion Pl., Suite F
Carlsbad,  CA  92010
Applicant Contact Joseph Caruso
Correspondent
Mriaudio, Inc.
5909 Sea Lion Pl., Suite F
Carlsbad,  CA  92010
Correspondent Contact Joseph Caruso
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/08/2019
Decision Date 01/06/2020
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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