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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name liver iron concentration imaging companion diagnostic for deferasirox
De Novo Number DEN130012
510(K) Number K124065
Device Name FERRISCAN R2-MRI ANALYSIS SYSTEM
Requester
resonance health analysis services pty, ltd.
3722 ave., sausalito
irvine,  CA  92606
Contact greg holland
Regulation Number892.1001
Classification Product Code
PCS  
Date Received01/02/2013
Decision Date 01/23/2013
Decision granted (DENG)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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