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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 K182218
Device Name FerriSmart Analysis System
Resonance Health Analysis Services Pty Ltd
141 Burswood Road
Burswood,  AU 6100
Applicant Contact Celine Royet
Emergo Global Representation LLC
141 Burswood Rd, Burswood 6100 - Australia
Perth,  AU
Correspondent Contact Celine Royet
Regulation Number892.1001
Classification Product Code
Date Received08/15/2018
Decision Date 11/30/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No