HEPAFAT SCAN


Device Classification Name

system, nuclear magnetic resonance imaging

510(k) Number K122035
Device Name HEPAFAT SCAN
Applicant
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
3722 ave. sausalito
irvine, 
CA 
92606

Applicant Contact greg holland
Correspondent
RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
3722 ave. sausalito
irvine, 
CA 
92606

Correspodent Contact greg holland
Regulation Number 892.1000
Classification Product Code
LNH  
Date Received 07/11/2012
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