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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox
510(k) Number K213776
Device Name LiverSmart
Applicant
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Perth,  AU 6100
Applicant Contact Mitchell Wells
Correspondent
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Perth,  AU 6100
Correspondent Contact Mitchell Wells
Classification Product Code
PCS  
Subsequent Product Code
LNH  
Date Received12/02/2021
Decision Date 12/29/2021
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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