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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 K043271
Device Name R2-MRI ANALYSIS SYSTEM
Applicant
Inner Vision Biometrics Pty, Ltd.
216 Stirling Hwy
Claremont, Perth,  AU 6010
Applicant Contact JANET PREUSS
Correspondent
Inner Vision Biometrics Pty, Ltd.
216 Stirling Hwy
Claremont, Perth,  AU 6010
Correspondent Contact JANET PREUSS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received11/26/2004
Decision Date 01/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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