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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
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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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