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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 K231459
Device Name HepaFatSmart (V2.0.0)
Applicant
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Burswood,  AU 6100
Applicant Contact Mitchell Wells
Correspondent
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Burswood,  AU 6100
Correspondent Contact Mitchell Wells
Regulation Number892.1000
Classification Product Code
LNH  
Date Received05/19/2023
Decision Date 06/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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