MRI-Q SYSTEM


Device Classification Name

system, image processing, radiological

510(k) Number K111222
Device Name MRI-Q SYSTEM
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 892.2050
Classification Product Code
LLZ  
Date Received 05/02/2011
Decision Date 07/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No