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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 K201039
Device Name HepaFat-AI
Applicant
Resonance Health Analysis Services Pty, Ltd.
141 Burswood Rd.
Perth,  AU 6100
Applicant Contact Alison Laws
Correspondent
Resonance Health Analysis Services Pty, Ltd.
141 Burswood Rd.
Perth,  AU 6100
Correspondent Contact Alison Laws
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/20/2020
Decision Date 12/07/2020
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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