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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 K122035
Model V1.0.0
Device Name HEPAFAT SCAN
Original Applicant
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
3722 ave. sausalito
irvine,  CA  92606
Original Contact greg holland
Regulation Number892.1000
Classification Product Code
LNH  
Date Received07/11/2012
Decision Date 12/13/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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