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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 K124065
Device Name FERRISCAN R2-MRI ANALYSIS SYSTEM
Original Applicant
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
3722 ave. sausalito
irvine,  CA  92606
Original Contact greg holland
Regulation Number892.1001
Classification Product Code
PCS  
Date Received01/02/2013
Decision Date 01/23/2013
Decision de novo petitions granted (AN)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
FOI Item Approval Letter
FDA Review Decision Summary
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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